New combo shows promise for Tough-to-Treat colorectal cancer
NCT ID NCT05171660
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding the immunotherapy drug sintilimab to standard chemotherapy and bevacizumab helps people with a specific type of advanced colorectal cancer (RAS-mutant, MSS) live longer without their cancer growing. About 446 adults who have not had prior treatment will be randomly assigned to receive either the standard therapy or the standard therapy plus sintilimab. The study aims to see if the combination improves outcomes like tumor shrinkage and survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 446 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Dec 2026
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: 1. Male or female, age ≥ 18 years old, ≤ 75 years old 2. Metastatic colorectal adenocarcinoma confirmed by histology, metastases cannot be removed 3. RAS mutation, BRAF V600E wild type, and microsatellite stable 4. ECOG 0 to 1 5. Life expectancy is at least 12 weeks 6. Hematological examination absolute neutrophil count (ANC)\>1.5×109/L, hemoglobin\>8g/dL and platelet\>100×109/L (according to the normal value of clinical trial center) 7. Prothrombin time (PT) \< 1.5 times the upper limit of normal value and normal thromboplastin time (APTT) \< 1.5 times the upper limit of normal value 8. Laboratory examination, serum creatinine is less than or equal to 1.5 times the upper limit of the normal reference range (if serum creatinine is elevated, 24 hours of urine must be collected, except for 24 hours creatinine clearance \> 50ml/min) 9. When there is no liver metastasis, ALT or AST is less than or equal to 2.5 times the upper limit of the normal value reference range, serum total bilirubin is less than or equal to 1.5 times the upper limit of the normal value reference range; for patients with liver metastasis, ALT or AST is less than or equal to 5 times the upper limit of the normal value reference range, serum total bilirubin is less than or equal to 3 times the upper limit of the normal value reference range 10. Women of childbearing age must be willing to use adequate contraception during study drug treatment 11. Informed consent has been signed 12. According to the definition of RECIST 1.1, the investigator determined that the patient had a measurable disease. Tumor lesions located in previous radiotherapy areas are considered measurable if they demonstrate progression. Exclusion Criteria: 1. Active autoimmune disease requiring systemic treatment occurred in the previous 2 years. 2. Diagnosed as immunodeficiency or experimental treatment is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose. After consultation with the sponsor, the use of a physiological dose of corticosteroids may be approved. 3. Adverse events caused by anti-tumor monoclonal antibodies (mAbs) within 4 weeks prior to study day 1 or drugs received 4 weeks prior to the study have not recovered. 4. Adverse events caused by chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1, or previously received drugs, have not recovered (ie, ≤1 or reached baseline levels). Other malignancies that are progressing or require active treatment are known. Except for basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ that have undergone radical treatment. 5. Active central nervous system (CNS) metastasis and/or cancerous meningitis are known to exist. 6. There are active infections that require systemic treatment. 7. It is possible to confuse the test results, the medical history or disease evidence, the treatment or laboratory value abnormalities that hinder the subject's full participation in the study, or the investigator believes that participating in the study is not in the best interests of the subject. 8. There are known mental or substance abuse disorders that may have an impact on compliance with test requirements. 9. Female subjects who are pregnant or lactating, or who are expected to be pregnant during the planned trial period (from 120 days after screening visits to 120 days after the last dose of study treatment, or 180 days after the last dose of study treatment), or Male subjects whose spouse is pregnant. 10. A history of infection with human immunodeficiency virus (HIV) (HIV 1/2 antibody) is known. 11. Active hepatitis B or C. 12. Live vaccines were vaccinated within 30 days of the start date of the study treatment plan. 13. RAS wild type
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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.
Contacts and locations
Locations
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Xuefeng Fang
Hangzhou, Zhejiang, 310009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily pill replace chemotherapy for advanced colorectal cancer?
- Can a Three-Drug combo outsmart Hard-to-Treat colorectal cancer?
- Can two immune boosters outsmart Chemo-Resistant colon cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat colorectal tumors?
- Can a Two-Drug attack shrink Hard-to-Treat colorectal tumors?
- Can a four-drug cocktail shrink hard-to-treat colorectal cancer?