New cocktail of four drugs takes on advanced colorectal cancer
NCT ID NCT07395063
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of four drugs—irinotecan liposome, capecitabine, bevacizumab, and camrelizumab—as a second or later treatment for people with metastatic colorectal cancer. The study will enroll 68 participants and measure how long the disease stays under control. The goal is to see if this mix can shrink tumors and delay progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- irinotecan liposome, capecitabine, bevacizumab, and camrelizumab
- What this could lead to
- If this works, it could offer a new treatment option for people with metastatic colorectal cancer who have already tried one line of therapy.
- What could go wrong
- This is a small, early-phase trial with no control group, so results may not be definitive. The combination of drugs may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients pathologically diagnosed with colorectal cancer; * Received systemic treatment on the first line; * Age: 18 to 75 years old, gender not limited. * There must be at least one measurable lesion as the target lesion (in accordance with the RECIST v1.1 standard); * ECOG: 0-1; * Expected survival period ≥3 months; * Women of childbearing age must undergo a blood pregnancy test within 3 days before randomization, and the result must be negative. They must also be willing to take appropriate contraceptive measures during the trial and for 6 months after the end of treatment. For men, it should be agreed to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; * The subjects voluntarily joined this study and signed the informed consent form. Exclusion Criteria: * Patients with wild-type RAS and BRAF, whose primary lesion is located in the left colorectal tract, but who have not received cetuximab as the first-line treatment * Patients with advanced colorectal cancer who have MSI-H or dMMR * Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ * For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication * Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months * Those who need immunosuppressive therapy for organ transplantation * Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases * The baseline blood routine and biochemical indicators of the subjects did not meet the following criteria: hemoglobin ≥90g/L; The absolute neutrophil count (ANC) is ≥1.5×109/L; Platelet count ≥100×109/L; ALT and AST≤2.5 times the normal upper limit value; ALP≤2.5 times the normal upper limit value; Serum total bilirubin \<1.5 times the normal upper limit value; Serum creatinine \<1 times the upper limit of normal; Serum albumin ≥30g/L * Those known to have a deficiency of dihydropyrimidine dehydrogenase (DPD) * Those who are allergic to any investigational drug ingredients (such as irinotecan, irinotecan liposome, capecitabine, bevacizumab and camrelizumab) * Pregnant or breastfeeding women * Have received any of the following treatments: The concomitant medication contained CYP3A4, CYP2C8 strong suppressor/strong inducer or UGT1A1 strong suppressor within 2 weeks prior to randomization;Use immunosuppressants or systemic hormones for immunosuppressive purposes within 2 weeks before randomization (dose \>10mg/ day, prednisone or other equivalent therapeutic hormones); \<s:1\> Received radiotherapy within 2 weeks prior to randomization;Undergo major surgeries (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization;The patient has received any other clinical study drug treatment within 4 weeks prior to randomization, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study. \- Abnormal coagulation function, with a bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg/ day) and low-molecular-weight heparin (enoxaparin 40mg/ day and other low-molecular-weight heparin at equivalent doses) is permitted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can mindfulness together ease the burden of advanced cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat colorectal tumors?
- Blood test may reveal hidden cancer spread without scans