Unresectable Colorectal CancerNCT07333053
Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer
A study testing Transarterial infusion chemotherapy (TAIC) and Intravenous Chemotherapy（IVC） in people with Unresectable Colorectal Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive transarterial infusion chemotherapy (TAIC) followed by sequential intravenous chemotherapy (IVC) is clinically more effective than IVC alone in the treatment of unresectable colorectal cancer (uCRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Colorectal Cancer
- What is being tested?
- Transarterial infusion chemotherapy (TAIC) and Intravenous Chemotherapy（IVC）
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Histopathologically confirmed CRC adenocarcinoma;
- Locally advanced CRC confirmed as clinical T4 stage on CT/MRI imaging, with or without synchronous liver metastases;
- For patients with CRLM, hepatic tumor burden shall be lower than the burden of the primary colorectal lesion. Consequently, the multidisciplinary team (MDT) agree by consensus that CRC should be a priority target for treatment.
- No prior administration of chemotherapy, targeted therapy or radiotherapy for the current malignancy;
- Adequate haematological, heart, liver and renal functions are required, with the following specific criteria: white blood cell count≥4×109 /L, neutrophils≥1.5×109 /L, platelets≥100×10⁹ /L, haemoglobin≥100 g/L, total bilirubin≤34.2 μmol/L, aspartate aminotransferase≤100 IU/L, alanine aminotransferase≤100 IU/L, serum creatinine ≤133 μmol/L or creatinine clearance rate≥60 mL/min, and urine protein/creatinine<1;
Show all 9Show fewer
- Estimated survival is more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- All the patients in this study are required to sign an informed consent form.
Who cannot join
- Patients have other primary malignant tumors;
- Patients with recurrent CRC;
- Patients with distant metastases besides synchronous hepatic metastases (e.g., pulmonary, bone, or brain metastases);
- For patients with CRLM, the MDT consensus recommends a liver-first treatment strategy to avoid the risk of rapid hepatic lesion progression;
- CRC patients with gastrointestinal perforation
- Patients with malignant bowel obstruction refractory to conservative management;
Show all 10Show fewer
- Patients are allergic to the antitumor agents;
- Women pregnant, breastfeeding or planning to become pregnant;
- Patients receiving other antitumor therapies, such as chemotherapy, targeted therapy or radiotherapy;
- Patients with MSI-H/dMMR CRC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junpeng Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Xicheng, Beijing Municipality, 100053
Quanda Liu Chief physician, MD, 01088001037, hnzyydxwjp@163.com
hnzyydxwjp@163.com
About this study
Official title: FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: Protocol of an Open-Label, Multicentre, Randomised, Controlled, Phase Ⅱ Trial
This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive transarterial infusion chemotherapy (TAIC) followed by sequential intravenous chemotherapy (IVC) is clinically more effective than IVC alone in the treatment of unresectable colorectal cancer (uCRC).
Read the detailed description
CRC is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, IVC, radiotherapy, immunotherapy, targeted therapy, and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoral drug accumulation. Compared with IVC, TAIC involves selective arterial catheterization to deliver chemotherapeutic agents directly to the tumor feeding vessels. Hepatic tumors receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared to IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of uCRC. However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap. We hypothesize that intensive TAIC followed by sequential IVC yields superior clinical efficacy compared with IVC alone for the treatment of uCRC. This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive TAIC followed by sequential IVC is clinically more effective than IVC alone in the treatment of uCRC. Eligible patients will be randomly allocated into two groups upon enrolment: the intervention group (TAIC group) and the control group (IVC group). Patients will be randomly assigned at a 1:1 ratio with no blinding implemented. Randomization will be conducted by an independent trial statistician via a secure system with complete allocation concealment using the permuted block randomization method. Stratification factors consist of primary tumor location, presence of liver metastases, RAS/BRAF mutational status, and participating study center. Patients in the control group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. For patients with CRLM, targeted agent selection is determined based on the RAS and BRAF mutational status and the primary tumor location. The primary endpoint is ORR. The secondary endpoints include Quality-of-life (QoL), clinical complete response (cCR) rate, pathological complete response (pCR) rate, the rate of conversion to resection (CTR), overall survival (OS), progression-free survival (PFS), and AEs. Primary and secondary efficacy analyses will be conducted for both the intention-to-treat (ITT) population and the per-protocol (PP) population. Safety analyses will be based on patients who received at least one dose of the assigned study treatment. Categorical variables will be presented as counts and percentages, while continuous variables will be presented as means with standard deviations or medians with interquartile ranges, as appropriate. Pearson's chi-square test or Fisher's exact test will be used for between-group comparisons of categorical variables. Continuous variables will be compared using Student's t-test or the Mann-Whitney U test as appropriate. Longitudinal QoL scores will be analyzed using linear mixed-effects models for repeated measurements, which naturally accommodate missing data under the missing at random assumption. For time-to-event endpoints of OS and PFS, the Kaplan-Meier method and Cox proportional hazards regression analysis will be applied. Between-group survival differences will be assessed using the log-rank test. Hazard ratios (HRs) with 95% confidence intervals (CIs) will be estimated from Cox regression models. All statistical tests will be two-sided, and a P value < 0.05 will be considered statistically significant. All statistical analyses will be performed using the current version of R software. Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion.
For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. The IVC and targeted therapy regimens are the same as those in the IVC group. The dosage-calculation strategies of anticancer drugs, drug exposure and infusion durations, and supportive care, including symptom management and prevention of complications, do not differ significantly between TAIC and IVC groups. Treatment will be continued until disease progression (PD), unacceptable toxicity, or surgical resection. Prior to each TAIC procedure, the right femoral artery will be punctured using the Seldinger technique according to tumour vascular supply. A microcatheter will be advanced into the tumour-feeding branch of the superior mesenteric artery, inferior mesenteric artery or internal iliac artery. Chemotherapeutic agents will be administered through the microcatheter.
- Conditions
- Unresectable Colorectal Cancer
- Being tested
- Transarterial infusion chemotherapy (TAIC), Intravenous Chemotherapy（IVC）
- Keywords
- Transarterial Infusion Chemotherapy, Bevacizumab, Cetuximab, Colorectal Cancer, FOLFOX Protocol, Unresectable, Clinical Trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial infusion chemotherapy (TAIC)Procedure or surgery
TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity.
Intravenous Chemotherapy（IVC）Procedure or surgery
Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| TAIC Group | Experimental | Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. Before placing a microcatheter into the feeding artery of the CRC, transarterial chemoembolization is performed for the liver metastases in patients with CRLM. The iodized oil emulsion is prepared by mixing 4 mL of iodized oil with 20 mg of oxaliplatin powder. Through the microcatheter, 0.5 mL of the iodized oil emulsion is slowly injected into the liver tumors via the feeding arterial branches. The technical endpoint of embolization is the absence of additional tumor staining or stasis/near stasis of the tumor-feeding arteries. The IVC and targeted therapy regimens are the same as those in the IVC group. Receives: Procedure: Transarterial infusion chemotherapy (TAIC) |
| IVC group | Active comparator | Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion. For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location. Receives: Procedure: Intravenous Chemotherapy（IVC） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate is defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 for CRC and modified RECIST criteria for CRLM.
Measured: 8 weeks
Secondary outcomes (6)
Health-related quality of life
Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) 30-item QoL Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items covering five functioning scales (physical, social, emotional, role, and cognitive), nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, diarrhea, and financial impact), and a global health status scale. Referring to a recall period of one-week (except for physical function, which does not refer to a recall period at all), patients indicate their answers on a 4-point Likert scale. Linear converted scale scores range from 0 to 100. Higher scores on the functioning scales and on the global health status scale indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
Measured: 8 weeks
Clinical complete response
Clinical complete response is defined as no visible tumor on imaging examination.
Measured: 8 weeks
Pathological complete response
The pathological complete response is defined as the absence of invasive neoplastic cells upon microscopic examination of the tumor during surgery.
Measured: 8 weeks
The rate of conversion to resectable status
Assessment of resectability represents a complex biological and technical decision; definitions of resectability vary substantially and are contingent on technical expertise, institutional surgical volume, institutional experience, and access to multidisciplinary oncological care. For the present clinical trial, the following resectability criteria will be applied: (i) Following 4 cycles of conversion therapy, simultaneous or staged complete surgical resection of the primary tumor and liver metastases can be performed. (ii) The primary lesion can be resected en bloc with R0 margins. (iii) Liver metastases can be treated with radical ablation alone or combined with radical surgical resection to achieve R0 margins; the future liver remnant constitutes no less than 30%-40% of the total liver volume. (iv) Patients maintain acceptable general status and have no additional distant metastases precluding local radical treatment. (v) Regional lymph node metastases are amenable to complete surg
Measured: 8 weeks
Overall survival
Overall survival is calculated from the date of randomisation until death. Participants who are alive at the time of analysis were censored at the date of the latest time seen alive.
Measured: 3 years
Progression-free survival
PFS is defined as the time from randomization to progression or death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, PLA Rocket Force Characteristic Medical Center, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Hebei University, The First Hospital of Qinhuangdao, The Central Hospital of Handan City, The First People's Hospital of Jiujiang City, Changzhi Medical College, Zibo Boshan District Traditional Chinese Medicine Hospital, Hebei Yixian Hospital, Baoding Mancheng District People's Hospital, The Shanghai Yangpu Central Hospital
- Responsible party
- Principal investigator, Quanda Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Quanda Liu, MD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333053
- Sponsor's protocol ID
- 2025-268-KY
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, this study remains in the active implementation phase. Given that individual participant data (IPD) contains sensitive personal privacy information of research subjects, the investigators will not share the IPD with external researchers temporarily, in order to strictly comply with ethical requirements and fully protect the legitimate rights and interests of study participants.
Publications
Wang J, Sun Y, Chen L, Wang Z, Li K, Guo Y, Yao L, Duan L, Liu Q. FOLFOX-based transarterial infusion chemotherapy for unresectable colorectal cancer: protocol of an open-label, multicentre, randomised, controlled, phase II trial. BMJ Open. 2026 Sep 11;16(9):e119746. doi: 10.1136/bmjopen-2026-119746.
PubMed 42731846
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: Protocol of an Open-Label, Multicentre, Randomised, Controlled, Phase Ⅱ Trial
- ClinicalTrials.gov ID
- NCT07333053
- Acronym / sponsor ID
- 2025-268-KY
- Conditions
- Unresectable Colorectal Cancer
- Keywords
- Transarterial Infusion Chemotherapy, Bevacizumab, Cetuximab, Colorectal Cancer, FOLFOX Protocol, Unresectable, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, PLA Rocket Force Characteristic Medical Center, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Hebei University, The First Hospital of Qinhuangdao, The Central Hospital of Handan City, The First People's Hospital of Jiujiang City, Changzhi Medical College, Zibo Boshan District Traditional Chinese Medicine Hospital, Hebei Yixian Hospital, Baoding Mancheng District People's Hospital, The Shanghai Yangpu Central Hospital
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive transarterial infusion chemotherapy (TAIC) followed by sequential intravenous chemotherapy (IVC) is clinically more effective than IVC alone in the treatment of unresectable colorectal cancer (uCRC).
Detailed description
CRC is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, IVC, radiotherapy, immunotherapy, targeted therapy, and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoral drug accumulation. Compared with IVC, TAIC involves selective arterial catheterization to deliver chemotherapeutic agents directly to the tumor feeding vessels. Hepatic tumors receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared to IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of uCRC. However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap. We hypothesize that intensive TAIC followed by sequential IVC yields superior clinical efficacy compared with IVC alone for the treatment of uCRC. This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive TAIC followed by sequential IVC is clinically more effective than IVC alone in the treatment of uCRC. Eligible patients will be randomly allocated into two groups upon enrolment: the intervention group (TAIC group) and the control group (IVC group). Patients will be randomly assigned at a 1:1 ratio with no blinding implemented. Randomization will be conducted by an independent trial statistician via a secure system with complete allocation concealment using the permuted block randomization method. Stratification factors consist of primary tumor location, presence of liver metastases, RAS/BRAF mutational status, and participating study center. Patients in the control group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. For patients with CRLM, targeted agent selection is determined based on the RAS and BRAF mutational status and the primary tumor location. The primary endpoint is ORR. The secondary endpoints include Quality-of-life (QoL), clinical complete response (cCR) rate, pathological complete response (pCR) rate, the rate of conversion to resection (CTR), overall survival (OS), progression-free survival (PFS), and AEs. Primary and secondary efficacy analyses will be conducted for both the intention-to-treat (ITT) population and the per-protocol (PP) population. Safety analyses will be based on patients who received at least one dose of the assigned study treatment. Categorical variables will be presented as counts and percentages, while continuous variables will be presented as means with standard deviations or medians with interquartile ranges, as appropriate. Pearson's chi-square test or Fisher's exact test will be used for between-group comparisons of categorical variables. Continuous variables will be compared using Student's t-test or the Mann-Whitney U test as appropriate. Longitudinal QoL scores will be analyzed using linear mixed-effects models for repeated measurements, which naturally accommodate missing data under the missing at random assumption. For time-to-event endpoints of OS and PFS, the Kaplan-Meier method and Cox proportional hazards regression analysis will be applied. Between-group survival differences will be assessed using the log-rank test. Hazard ratios (HRs) with 95% confidence intervals (CIs) will be estimated from Cox regression models. All statistical tests will be two-sided, and a P value < 0.05 will be considered statistically significant. All statistical analyses will be performed using the current version of R software. Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion.
For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. The IVC and targeted therapy regimens are the same as those in the IVC group. The dosage-calculation strategies of anticancer drugs, drug exposure and infusion durations, and supportive care, including symptom management and prevention of complications, do not differ significantly between TAIC and IVC groups. Treatment will be continued until disease progression (PD), unacceptable toxicity, or surgical resection. Prior to each TAIC procedure, the right femoral artery will be punctured using the Seldinger technique according to tumour vascular supply. A microcatheter will be advanced into the tumour-feeding branch of the superior mesenteric artery, inferior mesenteric artery or internal iliac artery. Chemotherapeutic agents will be administered through the microcatheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAIC Group | Experimental | Procedure: Transarterial infusion chemotherapy (TAIC)Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. Before placing a microcatheter into the feeding artery of the CRC, transarterial chemoembolization is performed for the liver metastases in patients with CRLM. The iodized oil emulsion is prepared by mixing 4 mL of iodized oil with 20 mg of oxaliplatin powder. Through the microcatheter, 0.5 mL of the iodized oil emulsion is slowly injected into the liver tumors via the feeding arterial branches. The technical endpoint of embolization is the absence of additional tumor staining or stasis/near stasis of the tumor-feeding arteries. The IVC and targeted therapy regimens are the same as those in the IVC group. |
| IVC group | Active comparator | Procedure: Intravenous Chemotherapy（IVC）Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion. For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old;
- Histopathologically confirmed CRC adenocarcinoma;
- Locally advanced CRC confirmed as clinical T4 stage on CT/MRI imaging, with or without synchronous liver metastases;
- For patients with CRLM, hepatic tumor burden shall be lower than the burden of the primary colorectal lesion. Consequently, the multidisciplinary team (MDT) agree by consensus that CRC should be a priority target for treatment.
- No prior administration of chemotherapy, targeted therapy or radiotherapy for the current malignancy;
Key exclusion criteria (10 listed)
- Patients have other primary malignant tumors;
- Patients with recurrent CRC;
- Patients with distant metastases besides synchronous hepatic metastases (e.g., pulmonary, bone, or brain metastases);
- For patients with CRLM, the MDT consensus recommends a liver-first treatment strategy to avoid the risk of rapid hepatic lesion progression;
- CRC patients with gastrointestinal perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial infusion chemotherapy (TAIC)TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity. | Procedure or surgery | TAIC Group |
| Intravenous Chemotherapy（IVC）Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy. | Procedure or surgery | IVC group |
Primary outcome
Objective response rate
Time frame: 8 weeks
Objective response rate is defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 for CRC and modified RECIST criteria for CRLM.
6 secondary outcomes
Health-related quality of life
Time frame: 8 weeks
Clinical complete response
Time frame: 8 weeks
Pathological complete response
Time frame: 8 weeks
The rate of conversion to resectable status
Time frame: 8 weeks
Overall survival
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 42731846Wang J, Sun Y, Chen L, Wang Z, Li K, Guo Y, Yao L, Duan L, Liu Q. FOLFOX-based transarterial infusion chemotherapy for unresectable colorectal cancer: protocol of an open-label, multicentre, randomised, controlled, phase II trial. BMJ Open. 2026 Sep 11;16(9):e119746. doi: 10.1136/bmjopen-2026-119746.
- Individual participant dataSharing planned: Undecided. At present, this study remains in the active implementation phase. Given that individual participant data (IPD) contains sensitive personal privacy information of research subjects, the investigators will not share the IPD with external researchers temporarily, in order to strictly comply with ethical requirements and fully protect the legitimate rights and interests of study participants.
Related trials for Unresectable Colorectal Cancer
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junpeng Wang, MD contact
Quanda Liu, MD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial infusion chemotherapy (TAIC) and Intravenous Chemotherapy（IVC） in people with Unresectable Colorectal Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quanda Liu Chief physician, MD (01088001037, hnzyydxwjp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07333053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.