Status:
UNKNOWN
Envafolimab Combined With GEMOX in First-line Treatment of Advanced GBC
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Gallbladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The TOPAZ-1 study compared the advantages and disadvantages of immune checkpoint inhibitor anti-PD-L1 antibody combined with Gem/Cis chemotherapy (Gemcitabine and Cisplatin) and Gem/Cis chemotherapy a...
Eligibility Criteria
Inclusion
- Definite diagnosis of gallbladder carcinoma by histology or cytology；
- There is at least one measurable lesion (according to RECIST1.1);
- From 18 to 75 years old, ECOG physical strength score of 0-2;
- Basically normal bone marrow function: neutrophils \>1.5x10\^9/L, platelets \>100x10\^9/L;
- Adequate renal function: creatinine clearance \> 60ml/min;
- Adequate liver function: bilirubin ≤1.5ULN;
- No cardiac insufficiency or chest pain (medically uncontrollable); No myocardial infarction in the 12 months prior to study initiation;
- Estimated survival time ≥3 months;
- The patient must sign an informed consent form.
Exclusion
- Previous systematic therapy, including chemotherapy, immunotherapy and targeted therapy;
- Secondary malignancies or other neoplasms (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to study initiation;
- The presence of brain or meningeal metastasis;
- Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc. );
- Have received allogeneic organ transplantation (eg kidney transplantation, liver transplantation, heart transplantation, etc. );
- Patients who need long-term oral hormone therapy due to their underlying diseases;
- Patients with interstitial pneumonia and autoimmune hepatitis;
- Inflammatory infections during the active period of infection or other patients who may have disabilities receive planned treatment;
- Persons with a history of uncontrolled substance abuse or mental disorders;
- Patients with concomitant diseases that, in the judgment of the investigator, may seriously endanger their own safety or may interfere with the completion of the study;
- Patients with poor renal function;
- Untreated complete/incomplete ileus that prevents eating or interferes with systemic administration;
- Participated in other clinical trials;
- Pregnant and lactating women.
Key Trial Info
Start Date :
March 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06013943
Start Date
March 17 2023
End Date
December 1 2025
Last Update
September 15 2023
Active Locations (1)
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1
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China, 200438