Envafolimab Combined With GEMOX in First-line Treatment of Advanced GBC

Launched by EASTERN HEPATOBILIARY SURGERY HOSPITAL · Aug 25, 2023

Keywords

ClinConnect Summary

The TOPAZ-1 clinical trial is studying a new treatment for advanced gallbladder cancer by combining a medication called Envafolimab with standard chemotherapy (Gemcitabine and Cisplatin, known as GEMOX). This trial aims to find out if this combination can help patients live longer and have fewer problems with their cancer compared to chemotherapy alone. Envafolimab is a type of immunotherapy that works by helping the body’s immune system fight cancer, and it is given through a simple injection under the skin.

To join the trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of gallbladder cancer. They should also have good overall health, with functioning bone marrow, kidneys, and liver. Participants will receive the treatment for up to 12 months and will be closely monitored for any side effects. It’s important to know that individuals with certain medical conditions, previous cancer treatments, or specific health issues may not be eligible for this study. If you or a loved one is considering participation, it could be a valuable opportunity to access a new potential treatment while contributing to important research.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Definite diagnosis of gallbladder carcinoma by histology or cytology；
• • 2. There is at least one measurable lesion (according to RECIST1.1);
• • 3. From 18 to 75 years old, ECOG physical strength score of 0-2;
• • 4. Basically normal bone marrow function: neutrophils \>1.5x10\^9/L, platelets \>100x10\^9/L;
• • 5. Adequate renal function: creatinine clearance \> 60ml/min;
• • 6. Adequate liver function: bilirubin ≤1.5ULN;
• • 7. No cardiac insufficiency or chest pain (medically uncontrollable); No myocardial infarction in the 12 months prior to study initiation;
• • 8. Estimated survival time ≥3 months;
• • 9. The patient must sign an informed consent form.
• Exclusion Criteria:
• • 1. Previous systematic therapy, including chemotherapy, immunotherapy and targeted therapy;
• • 2. Secondary malignancies or other neoplasms (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to study initiation;
• • 3. The presence of brain or meningeal metastasis;
• • 4. Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc. );
• • 5. Have received allogeneic organ transplantation (eg kidney transplantation, liver transplantation, heart transplantation, etc. );
• • 6. Patients who need long-term oral hormone therapy due to their underlying diseases;
• • 7. Patients with interstitial pneumonia and autoimmune hepatitis;
• • 8. Inflammatory infections during the active period of infection or other patients who may have disabilities receive planned treatment;
• • 9. Persons with a history of uncontrolled substance abuse or mental disorders;
• • 10. 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;
• • 11. Patients with poor renal function;
• • 12. Untreated complete/incomplete ileus that prevents eating or interferes with systemic administration;
• • 13. Participated in other clinical trials;
• • 14. Pregnant and lactating women.