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A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation

NCT07229846•Yanqiao Zhang

View on ClinicalTrials.gov

Summary

This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E mutation. Patients will receive intravenous administration of Aipalolitovorelizumab (QL1706) injection + bevacizumab + oxaliplatin/irinotecan/fluorouracil/calcium folinate, along with oral capecitabine. After completing the corresponding treatment cycles, patients will enter the maintenance treatment phase as determined by the researcher. In the maintenance treatment phase, a 3-week treatment regimen of Aipalolitovorelizumab (QL1706) injection combined with bevacizumab and capecitabine will be adopted, with the administration method and dosage remaining unchanged. The primary endpoint of this study is objective response rate (ORR); the secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the ICF, male or female;
•2. Patients with histopathologically confirmed unresectable metastatic colorectal adenocarcinoma of MSS/pMMR type with known BRAF V600E mutation;
•3. Expected survival period ≥ 12 weeks;
•5. For subjects who have received neoadjuvant/adjuvant therapy previously, the time from the last treatment to recurrence or progression must exceed 6 months;
•6. Adverse events (AEs) related to previous treatment have recovered to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (except for alopecia);
•7. According to the RECIST version 1.1 criteria, the researcher assesses that there is at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions located in the previously irradiated area can also be regarded as eligible measurable lesions if progression is confirmed);
•8. Routine blood tests: No blood transfusion or use of blood products within 14 days. White blood cell count \> 3000/µl, absolute neutrophil count (ANC) ≥ 1500 cells/µl, platelet count ≥ 75,000/µl, hemoglobin ≥ 9.0 g/dL, left ventricular ejection fraction (LVEF) ≥ 50%, Fridericia-corrected QT interval (QTcF) \< 470 milliseconds, activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN);
•9. Bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN; if there is liver metastasis, ALT and AST ≤ 5 times ULN, total bilirubin (TBLL) ≤ 3 times ULN; creatinine \< 1.5 times ULN;
•10. ECOG PS score of 0-1 within 7 days before the first administration of the study drug;
•11. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-), and no active hepatitis is clinically determined. If HBsAg (+) or HBcAb (+), then hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \< 1000 copies/mL or 200 IU/mL (if the lower limit of detection in the research unit is \> 200 IU/mL, subjects with results below the lower limit of detection can be enrolled);
+4 more criteria

Exclusion Criteria

•1. Have other active malignant tumors within 5 years before the first administration of the study drug. Patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast can be enrolled;
•2. Have central nervous system (CNS) or leptomeningeal metastasis;
•3. Have received radiotherapy within 6 months before the start of study treatment; except for palliative radiotherapy for bone lesions performed more than 14 days before the start of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days before the first administration is not allowed;
•4. Have previously received treatment with targeted drugs against EGFR or VEGF/vascular endothelial growth factor receptor (VEGFR) targets (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of the above drugs, etc.);
•5. Have previously received any T-cell co-stimulation or immune checkpoint inhibitor therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell-targeted drugs;
•6. Have a known history of severe allergy to any study drug analogs or study drug excipients;
•7. Pleural effusion, pericardial effusion that cannot be controlled by appropriate intervention, or ascites that requires frequent drainage;
•8. Have had cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval ≥ 450 ms in males and ≥ 470 ms in females) within half a year (QTc interval is calculated by Fridericia formula);
•9. Have New York Heart Association (NYHA) class III or IV cardiac insufficiency, or echocardiography shows left ventricular ejection fraction (LVEF) \< 50%;
•10. Have a history of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation;
+27 more criteria

Locations (1)

Harbin Medical University Cancer Hosptital

Harbin, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2028

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Aipalolitovorelizumab

DRUG

XELOX + Bevacizumab

DRUG

mFOLFOX + Bevacizumab

DRUG

FOLFOXIRI + Bevacizumab

DRUG

Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab

DRUG

Contacts

Yanqiao Zhang, PhD

CONTACT

+86 138 4512 0210 yanqiaozhang@ems.hrbmu.edu.cn

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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: January 8, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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