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

Phase 2

Recruiting

• Conditions: Colorectal Carcinoma
• Interventions: Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine

• Registration Number: NCT05799820
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-29
• Status Verified: 2023-03
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-03-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL1706	QL1706	-
QL1706 in combination with bevacizumab and XELOX	QL1706	-
QL1706 in combination with bevacizumab and XELOX	Bevacizumab	-
QL1706 in combination with bevacizumab and XELOX	Oxaliplatin injection	-
QL1706 in combination with bevacizumab and XELOX	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to approximately 2 years	ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China