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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799820
• Other study ID #: QL1706-208
• Status: Recruiting
• Phase: Phase 2
• Start date: September 29, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Jin Li, MD
• Phone: +86 021-38804518
• Email: lijin[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• QL1706
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Bevacizumab
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Oxaliplatin injection
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
• Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause.	Up to approximately 2 years