An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

QL1706-208

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

2022-09-29

2024-03-30

2025-09-30

Recruiting

Early phase I

60

Inclusion Criteria: * 1. Subjects participate voluntarily and sign informed consent. * 2. Age ≥ 18 and ≤ 80 years old, male or female. * 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum. * 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: * 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers. * 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled). * 3. Has active autoimmune disease that has required systemic treatment in past 2 years. * 4. Significant cardiovascular disease.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-05-25