NCT05799820
Recruiting
Phase 2
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
ConditionsColorectal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine
- Conditions
- Colorectal Carcinoma
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects participate voluntarily and sign informed consent.
- •Age ≥ 18 and ≤ 80 years old, male or female.
- •Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
- •At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Exclusion Criteria
- •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.
- •Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
- •Has active autoimmune disease that has required systemic treatment in past 2 years.
- •Significant cardiovascular disease.
Arms & Interventions
QL1706 in combination with bevacizumab and XELOX
Intervention: Capecitabine
QL1706
Intervention: QL1706
QL1706 in combination with bevacizumab and XELOX
Intervention: QL1706
QL1706 in combination with bevacizumab and XELOX
Intervention: Bevacizumab
QL1706 in combination with bevacizumab and XELOX
Intervention: Oxaliplatin injection
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Secondary Outcomes
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Progression-free Survival (PFS)(Up to approximately 2 years)
Study Sites (1)
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