Colorectal Carcinoma
Conditions
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.
Interventions
DRUGQL1706
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
DRUGBevacizumab
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
DRUGCapecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| Overall Survival (OS) | Up to approximately 2 years | OS was defined as the time from randomization to death due to any cause. |
Countries
China
Contacts
Primary ContactJin Li, MD
Outcome results
None listed