Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial
Starting soon · Phase 2
Conditions studied: Colorectal Neoplasms Malignant, Neoplasm, Metastatic
In brief
Primary endpoint: objective response rate Secondary endpoints: PFS, OS and adverse events
Key facts
- Study ID
- NCT07722754
- Run by
- Guangdong Provincial People's Hospital
- People needed
- 160
- Starts
- 2026-08-01
- Expected to finish
- 2029-01-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Metastatic and unresectable colorectal adenocarcinom;
- RAS wild-type and MSS tumor;
- Measurable lesions;
- Failed to at least two lines of standard treatment containing fluoropyrimidine, irinotecan and bevacizumab;
- Eastern Cooperative Oncology Group performance status 2 or less;
- White blood cell≥ 3*10\^9/L, neutrophil≥ 1.5*10\^9/Lplatelet count≥75*10\^9/L, hemoglobin≥60g/L;
- Total serum bilirubin≤upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5*ULN or ≤5*ULN for subjects with liver metastasis;
- Creatinine ≤ ULN or creatinine clearance ≥ 80 mL/min;
- Urinary protein negative or 24-hour urinary protein ≤ 2g;
- Activated partial thromboplastin time≤ULN and international normalized ratio≤1.5;
- Any major surgery ≥ 4 weeks and any minor surgery ≥ 1 week and fully recovered from the procedure;
- Life expectancy > 3 months;
- Provide fully informed written consent;
You may not qualify if…
- Other aggressive malignancies within 3 years (Exceptions: non-melanoma skin cancer or carcinoma-in-situ of the cervix that has been treated);
- Allergy or intolerance to any of the study drugs;
- Human immunodeficiency virus positive;
- Concurrent anti-cancer therapy including radiation therapy, chemotherapy, targeted agents or biological agents not otherwise specified within two weeks;
- Malignant bowel obstruction;
- Prior treatment with PD-1 antibody;
- Autoimmune diseases;
- Significant bleeding events or pre-existing bleeding diathesis within 6 months (unless the source of bleeding has been resected);
- Gastrointestinal perforation within 12 months;
- Serious or non-healing wound, ulcer, or bone fracture;
- Blood pressure >= 160/90 mmHg after active anti-hypertensive therapy;
- Arterial or venous thrombotic or embolic events within 6 months (including but not limited to transient ischemic attack, cerebrovascular accident, unstable angina or myocardial infarction);
- Uncontrolled illness including active infection, symptomatic congestive heart failure, cardiac arrhythmia, respiratory failure, symptomatic pulmonary fibrosis, interstitial pneumonitis or psychiatric illness that may interfere with the conduct of the study;
- Known or suspected brain or central nervous system (CNS) metastases, or carcinomatous meningitis;
- Any of the following: pregnant, nursing, childbearing potential but unwilling to employ contraception.
Full record on ClinicalTrials.gov
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