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Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC

Assess and Compare the Efficacy and Safety of FOLFOX Combined With Cetuximab Versus FOLFOXIRI Combined With Bevacizumab When Both Used in Combination With QL1706 for First-line Treatment of Metastatic Colorectal Cancer With Left-sided Primary Tumors.

NCT07070713•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple randomization and allocation concealment methods. The treatment plans for the two groups are as follows: Group A: FOLFOXIRI (Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + Bevacizumab (5mg/kg, i.v, Q2W) Group B: FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + Cetuximab (500mg/m², i.v, Q2W) Both groups A and B will repeat the treatment every 2 weeks, for a maximum of 9 cycles. Then, the attending physician will decide whether to conduct maintenance treatment (Capecitabine or 5FU/LV with or without Bevacizumab is recommended). Both groups A and B will be combined with QL1706 (5mg/kg, i.v, Q3W) for a maximum of 52 weeks. Medication will continue until the researcher judges that there is no longer clinical benefit (the researcher makes a comprehensive judgment based on RECIST v1.1 imaging evaluation and clinical status, etc.), intolerable toxicity occurs, the subject withdraws informed consent, or other criteria for terminating treatment in the protocol are met, whichever comes first.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 75 years old.
•2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
•3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with the primary tumor located in the left-sided colon (from the splenic flexure to the rectum), including cecal adenocarcinoma.
•4. Presence of at least one evaluable lesion according to RECIST v1.1 criteria.
•5. The subject has provided sufficient tumor tissue samples through colonoscopy biopsy for MSI, TMB, and other tests.
•6. Tumors confirmed by tissue testing to be wild-type for KRAS, NRAS, and BRAF.
•7. Within 7 days prior to the first dose of study drug, laboratory tests meet the following criteria (no blood products, hematopoietic growth factors, albumin, or other corrective treatments within 14 days prior to testing): (1) Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), or ≤ 5 times ULN in the presence of liver metastases; total bilirubin (TBIL) ≤ 1.5 times ULN, or ≤ 2 times ULN in the presence of liver metastases; serum creatinine ≤ 1.5 times ULN, or creatinine clearance \> 50 mL/min (calculated by the Cockcroft-Gault formula). (2) Hematology: Hemoglobin (Hb) ≥ 9.0 g/dL. No red blood cell transfusions within 1 week prior to the baseline Hb test; absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L. No platelet transfusions within 1 week prior to the baseline platelet test. (3) Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN (for subjects receiving prophylactic anticoagulation therapy without active bleeding \[i.e., no bleeding within the past 14 days\], the investigator should determine that the INR is within a safe and effective therapeutic range). (4) Urinalysis: Urine protein ≤ 30 mg/dL (1+) by dipstick or routine urinalysis (if ≥ 2+, then a 24-hour urine protein quantification must be \< 1 g/24h).
•8. Estimated survival of at least 3 months.
•9. No contraindications to chemotherapy or immunotherapy.

Exclusion Criteria

•11. The subject must provide informed consent for the study prior to enrollment, voluntarily sign a written informed consent form, and be willing and able to comply with the study visit schedule, treatment plan, laboratory tests, and other study procedures.
•2. Presence of other active malignancies within the past 3 years, except for early malignancies that have been cured (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, thyroid cancer, basal cell or squamous cell carcinoma of the skin, etc.
•3. Previous systemic therapy for unresectable/metastatic colorectal cancer.
•4. Active autoimmune disease within the past 2 years requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive agents); however, replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) will not be considered systemic treatment and is permitted.
•5. Presence of immunodeficiency or receipt of long-term systemic corticosteroid therapy (daily dose \> 10 mg prednisone or equivalent corticosteroid) within 7 days prior to enrollment, or other immunosuppressive therapy.
•6. Uncontrolled diabetes mellitus; peripheral neuropathy ≥ Grade 2.
•7. Active tuberculosis, or receipt of anti-tuberculosis treatment within 1 year prior to enrollment.
•8. If hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive, the patient's HBV-DNA must be less than 500 IU/mL. For patients with active hepatitis B, the patient must have received antiviral therapy for at least 14 days prior to enrollment (according to local standard treatment, such as entecavir or tenofovir) and agree to continue effective antiviral therapy during the study.
•9. If HCV antibody is positive, HCV-RNA testing will be performed; if HCV-RNA \> 1,000 copies/mL, the patient will be excluded.
•10. Receipt of any live vaccine within 28 days prior to enrollment (e.g., vaccines for infectious diseases, such as influenza vaccine, varicella vaccine, etc.).
+11 more criteria

Locations (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Key Dates

Start Date

July 30, 2025

Primary Completion Date

February 28, 2028

Completion Date

August 30, 2028

Last Updated

July 17, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer With Left-sided Primary TumorImmunotherapy

Interventions

FOLFOXIRI + QL1706 + Bevacizumab

DRUG

FOLFOX+QL1706+Cetuximab

DRUG

Contacts

rongbo lin

CONTACT

13705919382 rongbo_lin@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC

Inclusion Criteria

Exclusion Criteria

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