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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05799820
Other study ID # QL1706-208
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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