Colorectal CancerPhase 2OPTICAL-2NCT05571644
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer
A Phase 2 study testing mFOLFOXIRI + Cadonilimab, mFOLFOX6 and mFOLFOXIRI in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mFOLFOXIRI + Cadonilimab, mFOLFOX6 and mFOLFOXIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 15 Aug 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70;
- Colorectal adenocarcinoma with definite histological evidence;
- ECOG Performance status score is 0-1
- Colon cancer was evaluated as T3>5mm or T4 by contrast-enhanced CT examination of the chest, abdomen and pelvis, and distant displacement was excluded; Rectal cancer was graded as T3-4 and/or N+ by pelvic contrast-enhanced MRI examination, and the lower margin of the tumor was less than 12cm away from the anal margin. Distant metastasis was excluded by chest, abdomen and pelvis CT.
- The primary rectal tumor was assessed as complete resections by a multidisciplinary collaboration group on colorectal cancer, including at least 2 gastrointestinal surgeons and 1 radiologist;
- No previous systemic antitumor therapy for colorectal cancer, including cytotoxic drugs, immunotherapy, molecular targeted therapy, etc.;
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- Adequate organ function based on the following laboratory test values obtained within 7 days prior to treatment:
- Hemoglobin ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤1.5× upper limit of normal value (UNL), aspartate transferase ≤2×UNL, alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL;
- Willing and able to comply with research protocols and visit plans.
Who cannot join
- The patient was complicated with obstruction, active bleeding, or perforation and required emergency surgery or stent placement;
- Active, known or suspected autoimmune diseases (except type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune conditions, or autoimmune diseases that are not expected to recur in the absence of external triggers);
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
- Known allergy to the treatment drug or allergy or intolerance to its ingredients;
- Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic organ resection, etc. within the previous 4 weeks (the surgical incision should be completely healed before enrollment);
- Existing or coexisting other active malignancies (except those that have been treated with curative therapy and remain disease-free for more than 5 years or carcinoma in situ that can be cured by adequate treatment);
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- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (Cytotoxic T-lymphocyte-associated protein 4) antibody. Ctla-4) antibodies or other drugs/antibodies that act on T-cell costimulatory or checkpoint pathways;
- Had active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 6 months prior to study enrollment; Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis, occurred within the previous 6 months;
- The New York Heart Association (NYHA) class II or higher congestive Heart failure (see Appendix 3);
- Presence of active inflammatory bowel disease or other colorectal disease leading to chronic diarrhea;
- The presence of any toxicity (Common Terminology Criteria for Adverse Events, CTCAE) (version 5.0) grade 1 or above (except anemia, alopecia, and skin pigmentation) caused by previous treatment that has not subsided;
- Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function and other lung diseases;
- Active tuberculosis (TB), receiving anti-TB therapy or receiving anti-TB therapy within 1 year before the first dose;
- Persons with known syphilis infection requiring treatment;
- Had used immunosuppressive drugs within 4 weeks before the first dose, Does not include the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or other equivalent dose glucocorticoids), allows for prevention of allergic reactions, or treatment of diseases such as asthma, chronic obstructive pulmonary disease of breathing difficulties for the temporary use of glucocorticoid;
- Receive live attenuated vaccine within 4 weeks before the first dose or during the study period;
- Pregnant or lactating women; Women of reproductive age (< 2 years after last menstruation) who do not use or refuse to use effective non-hormonal contraception or men at risk of having children.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanghong Deng, PhD, 008613925106525, dengyanh@mail.sysu.edu.cn
Yanhong Deng, PhD
About this study
Official title: Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)
Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC.
Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.
Read the detailed description
This study was a prospective, randomized, uncontrolled phase II trial to evaluate the efficacy of mFOLFOXIRI combined with AK104 neoadjuvant therapy versus mFOLFOX6 neoadjuvant therapy in LARC.
The inclusion criteria: locally advanced colon cancer (T3>5mm or T4 on enhanced CT assessment, with distant metastasis excluded); Locally advanced rectal cancer (pelvic MR assessment as stage ii-iii, less than 12cm from the anal margin, no distant metastasis).
Group A: mFOLFOXIRI combined with Cadonilimab (AK104) for 6 cycles before surgery
Group B: 6 cycles of neoadjuvant chemotherapy with mFOLFOX6 before surgery
Group C: 6 cycles of neoadjuvant chemotherapy with mFOLFOXIRI before surgery
Group D (exploratory cohort): mFOLFOXIRI combined with Cadonilimab (AK104) and fruquintinib for 3 months before surgery (not for randomised)
All groups were re-evaluated after 3 cycles and 6 cycles of treatment. If surgery was feasible after multidisciplinary evaluation, TME resection was performed, and adjuvant treatment was performed according to standard treatment after operation. For locally advanced rectal cancer, preoperative pelvic enhanced MRI was used to evaluate tumor regression after 6 cycles of preoperative treatment. For patients who still had MRF+ and/or T4 after treatment, additional short-course radiotherapy was allowed.
- Conditions
- Colorectal Cancer
- Being tested
- mFOLFOXIRI + Cadonilimab, mFOLFOX6, mFOLFOXIRI, mFOLFOXIRI+AK104+fruquintinib
- Keywords
- Neoadjuvant therapy, mFOLFOXIRI, Cadonilimab (AK104), mFOLFOX6
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOXIRI + CadonilimabDrug
Also called Oxaliplatin, Irinotecan, 5-Fluorouracil, Leucovorin
Cadonilimab（AK104）6mg/kg, intravenous d for 60 minutes, followed by mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery
mFOLFOX6Drug
Also called Oxaliplatin, 5-Fluorouracil, Leucovorin
mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycels before surgery
mFOLFOXIRIDrug
Also called Oxaliplatin, Irinotecan, 5-Fluorouracil
mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery
mFOLFOXIRI+AK104+fruquintinibDrug
Cadonilimab（AK104）6mg/kg, intravenous d for 60 minutes, followed by mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles, and fruquintinib (3mg Qd, D1-21, Q4W for 3 months) before surgery
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOXIRI+Cadonilimab | Experimental | Patients will receive neoadjuvant treatment with mFOLFOXIRI plus cadonilimab for 6 cycles before surgey Receives: Drug: mFOLFOXIRI + Cadonilimab |
| mFOLFOX6 | Active comparator | Patients will receive neoadjuvant mFOLFOX6 chemotherapy every two weeks for 6 cycles before surgery. Receives: Drug: mFOLFOX6 |
| mFOLFOXIRI | Active comparator | Patients will receive neoadjuvant mFOLFOXIRI chemotherapy every two weeks for 6 cycles before surgery. Receives: Drug: mFOLFOXIRI |
| mFOLFOXIRI+AK104+fruquintinib | Other | Therapeutic Exploratory：Patients will receive neoadjuvant treatment with mFOLFOXIRI plus cadonilimab for 6 cycles and fruquintinib (3mg Qd, D1-21, Q4W for 3 months) before surgey Receives: Drug: mFOLFOXIRI+AK104+fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rates
Proportion of patients experiencing a pCR to preoperative treatment in each group
Measured: 1 year
Secondary outcomes (3)
Major pathological response rates
The proportion of patients experiencing a major pathological response (≤10% of residual viable tumor in the surgical specimen) to preopeartive treatment in each group
Measured: 1 year
Disease-free survival (DFS)
Defined as the time from randomization to relapse, metastasis or death from any cause.
Measured: 3 years
Local recurrence rate
Defined as the time from randomization to local recurrence.
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 posted7 Oct 2022
- Study start10 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Aug 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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Yanhong Deng, Ph.D, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571644
- Sponsor's protocol ID
- GIHSYSU-15
- Acronym
- OPTICAL-2
- Status last verified
- Jul 2025
- First submitted
- 6 Oct 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang J, Qi S, Hu H, He X, Huang L, Zhou J, Wang H, Wu X, Kang L, Huang M, He Z, Wang H, Chen D, Zhai X, Xie X, Ling J, Zhang Y, Hu J, Li S, Wu Z, Yang T, Cai R, Cai Y, Zhong L, Li W, Shi L, Wang C, Huang Y, Zhao Y, Cao W, Qin G, Deng Y. Neoadjuvant mFOLFOXIRI with or without cadonilimab versus mFOLFOX6 in locally advanced colorectal cancer: A randomized phase 2 trial (OPTICAL-2). Med. 2026 Jun 12;7(6):101141. doi: 10.1016/j.medj.2026.101141. Epub 2026 May 13.
PubMed 42134324
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)
- ClinicalTrials.gov ID
- NCT05571644
- Acronym / sponsor ID
- OPTICAL-2 / GIHSYSU-15
- Conditions
- Colorectal Cancer
- Keywords
- Neoadjuvant therapy, mFOLFOXIRI, Cadonilimab (AK104), mFOLFOX6
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 7 Oct 2022 (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.
Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC.
Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.
Detailed description
This study was a prospective, randomized, uncontrolled phase II trial to evaluate the efficacy of mFOLFOXIRI combined with AK104 neoadjuvant therapy versus mFOLFOX6 neoadjuvant therapy in LARC.
The inclusion criteria: locally advanced colon cancer (T3>5mm or T4 on enhanced CT assessment, with distant metastasis excluded); Locally advanced rectal cancer (pelvic MR assessment as stage ii-iii, less than 12cm from the anal margin, no distant metastasis).
Group A: mFOLFOXIRI combined with Cadonilimab (AK104) for 6 cycles before surgery
Group B: 6 cycles of neoadjuvant chemotherapy with mFOLFOX6 before surgery
Group C: 6 cycles of neoadjuvant chemotherapy with mFOLFOXIRI before surgery
Group D (exploratory cohort): mFOLFOXIRI combined with Cadonilimab (AK104) and fruquintinib for 3 months before surgery (not for randomised)
All groups were re-evaluated after 3 cycles and 6 cycles of treatment. If surgery was feasible after multidisciplinary evaluation, TME resection was performed, and adjuvant treatment was performed according to standard treatment after operation. For locally advanced rectal cancer, preoperative pelvic enhanced MRI was used to evaluate tumor regression after 6 cycles of preoperative treatment. For patients who still had MRF+ and/or T4 after treatment, additional short-course radiotherapy was allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mFOLFOXIRI+Cadonilimab | Experimental | Drug: mFOLFOXIRI + CadonilimabPatients will receive neoadjuvant treatment with mFOLFOXIRI plus cadonilimab for 6 cycles before surgey |
| mFOLFOX6 | Active comparator | Drug: mFOLFOX6Patients will receive neoadjuvant mFOLFOX6 chemotherapy every two weeks for 6 cycles before surgery. |
| mFOLFOXIRI | Active comparator | Drug: mFOLFOXIRIPatients will receive neoadjuvant mFOLFOXIRI chemotherapy every two weeks for 6 cycles before surgery. |
| mFOLFOXIRI+AK104+fruquintinib | Other | Drug: mFOLFOXIRI+AK104+fruquintinibTherapeutic Exploratory：Patients will receive neoadjuvant treatment with mFOLFOXIRI plus cadonilimab for 6 cycles and fruquintinib (3mg Qd, D1-21, Q4W for 3 months) before surgey |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-70;
- Colorectal adenocarcinoma with definite histological evidence;
- ECOG Performance status score is 0-1
- Colon cancer was evaluated as T3>5mm or T4 by contrast-enhanced CT examination of the chest, abdomen and pelvis, and distant displacement was excluded; Rectal cancer was graded as T3-4 and/or N+ by pelvic contrast-enhanced MRI examination, and the lower margin of the tumor was less than 12cm away from the anal margin. Distant metastasis was excluded by chest, abdomen and pelvis CT.
- The primary rectal tumor was assessed as complete resections by a multidisciplinary collaboration group on colorectal cancer, including at least 2 gastrointestinal surgeons and 1 radiologist;
Key exclusion criteria (17 listed)
- The patient was complicated with obstruction, active bleeding, or perforation and required emergency surgery or stent placement;
- Active, known or suspected autoimmune diseases (except type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune conditions, or autoimmune diseases that are not expected to recur in the absence of external triggers);
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
- Known allergy to the treatment drug or allergy or intolerance to its ingredients;
- Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic organ resection, etc. within the previous 4 weeks (the surgical incision should be completely healed before enrollment);
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 |
|---|---|---|
| mFOLFOXIRI + CadonilimabAlso: Oxaliplatin, Irinotecan, 5-Fluorouracil, LeucovorinCadonilimab（AK104）6mg/kg, intravenous d for 60 minutes, followed by mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery | Drug | mFOLFOXIRI+Cadonilimab |
| mFOLFOX6Also: Oxaliplatin, 5-Fluorouracil, LeucovorinmFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycels before surgery | Drug | mFOLFOX6 |
| mFOLFOXIRIAlso: Oxaliplatin, Irinotecan, 5-FluorouracilmFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery | Drug | mFOLFOXIRI |
| mFOLFOXIRI+AK104+fruquintinibCadonilimab（AK104）6mg/kg, intravenous d for 60 minutes, followed by mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles, and fruquintinib (3mg Qd, D1-21, Q4W for 3 months) before surgery | Drug | mFOLFOXIRI+AK104+fruquintinib |
Primary outcome
Pathological complete response (pCR) rates
Time frame: 1 year
Proportion of patients experiencing a pCR to preoperative treatment in each group
3 secondary outcomes
Major pathological response rates
Time frame: 1 year
Disease-free survival (DFS)
Time frame: 3 years
Local recurrence rate
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 23 Jul 2025.
- Derived from this study: PubMed 42134324Zhang J, Qi S, Hu H, He X, Huang L, Zhou J, Wang H, Wu X, Kang L, Huang M, He Z, Wang H, Chen D, Zhai X, Xie X, Ling J, Zhang Y, Hu J, Li S, Wu Z, Yang T, Cai R, Cai Y, Zhong L, Li W, Shi L, Wang C, Huang Y, Zhao Y, Cao W, Qin G, Deng Y. Neoadjuvant mFOLFOXIRI with or without cadonilimab versus mFOLFOX6 in locally advanced colorectal cancer: A randomized phase 2 trial (OPTICAL-2). Med. 2026 Jun 12;7(6):101141. doi: 10.1016/j.medj.2026.101141. Epub 2026 May 13.
- Individual participant dataSharing planned: Undecided
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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.
Yanhong Deng, Ph.D principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOXIRI + Cadonilimab, mFOLFOX6 and mFOLFOXIRI in people with Colorectal Cancer, run by Sun Yat-sen University 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 17 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 23 Jul 2025. 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.
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?
Contact Yanhong Deng, Ph.D (00862013925106525, dengyanh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rates (time frame: 1 year). 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 NCT05571644, 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 23 Jul 2025.