QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Drug: QL1706
* Drug: Bevacizumab
* Drug: Oxaliplatin injection
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1706<br> | Drug: QL1706<br>* 5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle<br>|
| Experimental: QL1706 in combination with bevacizumab and XELOX<br> | Drug: QL1706<br>* 5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle<br>Drug: Bevacizumab<br>* 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle<br>Drug: Oxaliplatin injection<br>* 130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle<br>Drug: Capecitabine<br>* 1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 2 years | 
| Duration of Response (DOR) | DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 2 years | 
| Progression-free Survival (PFS) | PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 2 years | 
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | Up to approximately 2 years |