Colorectal Cancer Liver Metastases (CRLM)Phase 2NCT07570914
Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases
A Phase 2 study testing Liposomal Irinotecan, Oxaliplatin and Capecitabine in people with Colorectal Cancer Liver Metastases (CRLM) and Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Liver Metastases (CRLM), Colorectal Cancer, Liver Metastasis
- What is being tested?
- Liposomal Irinotecan, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 May 2032
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years.
- Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.
- Histologically confirmed colorectal cancer liver metastases.
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
- Clinical risk score of 3 or higher.
Show all 11Show fewer
- Adequate bone marrow function, defined as absolute neutrophil count >2 × 10^9/L, hemoglobin >9.0 g/dL, and platelet count >100 × 10^9/L.
- Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula.
- Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal.
- Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment.
- Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.
Who cannot join
- Contraindication to capecitabine, oxaliplatin, or irinotecan.
- Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.
- Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.
- Dihydropyrimidine dehydrogenase deficiency.
- History of severe cardiovascular disease resulting in inability to tolerate treatment.
- Peripheral neuropathy greater than Grade 1.
Show all 13Show fewer
- History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.
- History of allogeneic organ transplantation.
- Requirement for renal dialysis.
- Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.
- Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance.
- Participation in another clinical trial currently or within 4 weeks before enrollment.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
About this study
Official title: An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection.
Eligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.
Read the detailed description
Colorectal cancer commonly metastasizes to the liver, and recurrence after radical resection of colorectal cancer liver metastases remains frequent, particularly in the liver. Systemic adjuvant chemotherapy is commonly used after resection to eliminate potential micrometastatic disease; however, systemic chemotherapy may have limited local efficacy in the liver and may be associated with systemic toxicity.
Hepatic arterial infusion chemotherapy delivers chemotherapy directly into the hepatic arterial supply. Because liver tumors are mainly supplied by the hepatic artery, this approach may increase local drug concentration in the liver while reducing systemic exposure. Liposomal irinotecan is a liposomal formulation of irinotecan designed to improve drug stability, prolong circulation, enhance tumor accumulation, and potentially reduce systemic toxicity.
This study will explore whether hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine can improve disease-free survival and hepatic recurrence-free survival while maintaining an acceptable safety profile in patients at high risk of hepatic recurrence after radical resection of colorectal cancer liver metastases.
- Being tested
- Liposomal Irinotecan, Oxaliplatin, Capecitabine, hepatic arterial infusion chemotherapy (HAIC)
- Keywords
- Colorectal cancer, Colorectal cancer liver metastases, Postoperative adjuvant therapy, Hepatic arterial infusion chemotherapy, Liposomal irinotecan, Oxaliplatin, Capecitabine, Disease-free survival, Hepatic recurrence-free survival, No evidence of disease
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal IrinotecanDrug
Liposomal irinotecan 50 mg/m^2 will be administered by hepatic arterial infusion over 90 minutes on Day 1 of each 21-day cycle.
OxaliplatinDrug
Oxaliplatin 100 mg/m^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
CapecitabineDrug
Capecitabine 1000 mg/m^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle.
hepatic arterial infusion chemotherapy (HAIC)Procedure or surgery
Hepatic arterial infusion chemotherapy will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine | Experimental | Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine. Each treatment cycle is 21 days. Treatment will be administered for 2 to 4 cycles. After 2 cycles, the investigator will decide whether to stop treatment or continue for another 2 cycles based on efficacy and tolerability. Receives: Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: hepatic arterial infusion chemotherapy (HAIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Disease-Free Survival Rate
The 3-year disease-free survival rate is defined as the proportion of participants who remain free of tumor recurrence, metastasis, or disease progression at 3 years after initiation of study treatment.
Measured: 3 years from initiation of study treatment.
Secondary outcomes (3)
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the end of the study will be censored at the date they were last known to be alive.
Measured: From enrollment to death from any cause, assessed for up to 3 years.
Hepatic Recurrence-Free Survival
Hepatic recurrence-free survival is defined as the time interval from completion of study treatment to the first recurrence of tumor in the liver.
Measured: From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events, including overall adverse events, adverse events by grade, Grade 3 or higher adverse events, and serious adverse events. Adverse events will be graded according to NCI CTCAE version 5.0.
Measured: From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver Metastases (CRLM)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570914
- Sponsor's protocol ID
- CSPC-TJ-CRC-05
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in future publications will be shared, including demographic and baseline characteristics, surgical and disease status, treatment exposure, efficacy outcome data, safety data, recurrence data, survival data, and follow-up data. Data that could directly or indirectly identify participants, signed informed consent forms, raw source documents, and other confidential medical records will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT07570914
- Acronym / sponsor ID
- CSPC-TJ-CRC-05
- Keywords
- Colorectal cancer, Colorectal cancer liver metastases, Postoperative adjuvant therapy, Hepatic arterial infusion chemotherapy, Liposomal irinotecan, Oxaliplatin, Capecitabine, Disease-free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2032 (estimated)
- First posted
- 6 May 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, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection.
Eligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.
Detailed description
Colorectal cancer commonly metastasizes to the liver, and recurrence after radical resection of colorectal cancer liver metastases remains frequent, particularly in the liver. Systemic adjuvant chemotherapy is commonly used after resection to eliminate potential micrometastatic disease; however, systemic chemotherapy may have limited local efficacy in the liver and may be associated with systemic toxicity.
Hepatic arterial infusion chemotherapy delivers chemotherapy directly into the hepatic arterial supply. Because liver tumors are mainly supplied by the hepatic artery, this approach may increase local drug concentration in the liver while reducing systemic exposure. Liposomal irinotecan is a liposomal formulation of irinotecan designed to improve drug stability, prolong circulation, enhance tumor accumulation, and potentially reduce systemic toxicity.
This study will explore whether hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine can improve disease-free survival and hepatic recurrence-free survival while maintaining an acceptable safety profile in patients at high risk of hepatic recurrence after radical resection of colorectal cancer liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine | Experimental | Drug: Liposomal Irinotecan, Drug: Oxaliplatin, Drug: Capecitabine, Procedure: hepatic arterial infusion chemotherapy (HAIC)Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine. Each treatment cycle is 21 days. Treatment will be administered for 2 to 4 cycles. After 2 cycles, the investigator will decide whether to stop treatment or continue for another 2 cycles based on efficacy and tolerability. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 75 years.
- Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.
- Histologically confirmed colorectal cancer liver metastases.
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
Key exclusion criteria (13 listed)
- Contraindication to capecitabine, oxaliplatin, or irinotecan.
- Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.
- Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.
- Dihydropyrimidine dehydrogenase deficiency.
- History of severe cardiovascular disease resulting in inability to tolerate treatment.
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 |
|---|---|---|
| Liposomal IrinotecanLiposomal irinotecan 50 mg/m^2 will be administered by hepatic arterial infusion over 90 minutes on Day 1 of each 21-day cycle. | Drug | Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine |
| OxaliplatinOxaliplatin 100 mg/m^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle. | Drug | Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine |
| CapecitabineCapecitabine 1000 mg/m^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle. | Drug | Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine |
| hepatic arterial infusion chemotherapy (HAIC)Hepatic arterial infusion chemotherapy will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment. | Procedure or surgery | Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine |
Primary outcome
3-Year Disease-Free Survival Rate
Time frame: 3 years from initiation of study treatment.
The 3-year disease-free survival rate is defined as the proportion of participants who remain free of tumor recurrence, metastasis, or disease progression at 3 years after initiation of study treatment.
3 secondary outcomes
Overall Survival
Time frame: From enrollment to death from any cause, assessed for up to 3 years.
Hepatic Recurrence-Free Survival
Time frame: From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.
Incidence and Severity of Adverse Events
Time frame: From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 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 6 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in future publications will be shared, including demographic and baseline characteristics, surgical and disease status, treatment exposure, efficacy outcome data, safety data, recurrence data, survival data, and follow-up data. Data that could directly or indirectly identify participants, signed informed consent forms, raw source documents, and other confidential medical records will not be shared.
Related trials for Colorectal Cancer Liver Metastases (CRLM)
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
Not yet recruitingPhase 2
A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
RecruitingObservational study
Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases
Colorectal Cancer Liver Metastases (CRLM), Metastatic Colorectal Carcinoma (mCRC)
RecruitingPhase 2
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
Colorectal Cancer Liver Metastases (CRLM)
RecruitingObservational study
AI-Based Prediction of Liver Metastasis in Colorectal Cancer (A Retrospective Study)
Colorectal Cancer Liver Metastases (CRLM)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Irinotecan, Oxaliplatin and Capecitabine in people with Colorectal Cancer Liver Metastases (CRLM) and Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Disease-Free Survival Rate (time frame: 3 years from initiation of study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.