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Trial Title:
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
NCT ID:
NCT05799820
Condition:
Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
QL1706
Arm group label:
QL1706 in combination with bevacizumab and XELOX
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
QL1706 in combination with bevacizumab and XELOX
Intervention type:
Drug
Intervention name:
Oxaliplatin injection
Description:
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
QL1706 in combination with bevacizumab and XELOX
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of
each 21-day cycle
Arm group label:
QL1706 in combination with bevacizumab and XELOX
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li
Phone:
021-38804518
Start date:
September 29, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05799820
