Back to resultsQL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
Primary Purpose
Colorectal Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QL1706
Bevacizumab
Oxaliplatin injection
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
QL1706
QL1706 in combination with bevacizumab and XELOX
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Secondary Outcome Measures
Disease Control Rate (DCR)
DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Duration of Response (DOR)
DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Progression-free Survival (PFS)
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Full Information
NCT ID
NCT05799820
First Posted
March 23, 2023
Last Updated
May 23, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05799820
Brief Title
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL1706
Arm Type
Experimental
Arm Title
QL1706 in combination with bevacizumab and XELOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
QL1706
Intervention Description
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin injection
Intervention Description
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time Frame
Up to approximately 2 years
Title
Duration of Response (DOR)
Description
DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time Frame
Up to approximately 2 years
Title
Progression-free Survival (PFS)
Description
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time Frame
Up to approximately 2 years
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Li, MD
Phone
+86 021-38804518
Email
lijin@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li
Phone
021-38804518
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
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