Combining Envafolimab with Gemox for treating advanced gallbladder cancer

Envafolimab Combined With GEMOX in First-line Treatment of Advanced Gallbladder Cancer : A Single Center, Single Arm, Phase II Trial

This study is testing if combining a new immune therapy called Envafolimab with standard chemotherapy can help adults with advanced gallbladder cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eastern Hepatobiliary Surgery Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Envafolimab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06013943 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Envafolimab, an immune checkpoint inhibitor, when combined with Gemox chemotherapy (gemcitabine and cisplatin) as a first-line treatment for advanced gallbladder cancer. The study aims to evaluate whether this combination can improve progression-free survival and overall survival compared to standard chemotherapy alone. Eligible participants will be adults aged 18 to 75 with a confirmed diagnosis of gallbladder carcinoma and measurable lesions. The trial will assess the safety and efficacy of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of gallbladder carcinoma and adequate organ function.

Not a fit: Patients with previous systemic therapy or those with brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced gallbladder cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of immune checkpoint inhibitors and chemotherapy in other cancers, indicating potential for success in this approach.

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.

Where this trial is running

Shanghai, Shanghai

• Easter hepatobiliary surgery hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhengang Yuan, PhD — Eastern Hepatobiliary Surgery Hospital, Navy Medical University
• Study coordinator: Zhengang Yuan, PhD

Conditions Gallbladder Cancer; Envafolimab