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New combo shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT05171660

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 446 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Xuefeng Fang

    Hangzhou, Zhejiang, 310009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.