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Efficacy and safety of the GEMOX regimen in combination with or without tripleizumab for conversion to initially unresectable biliary tract cancer

Efficacy and safety of the GEMOX regimen in combination with or without tripleizumab for conversion to initially unresectable biliary tract cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039129
Enrollment
Unknown
Registered
2020-10-17
Start date
2020-05-11
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

Trial group:GEMOX+Tripleitriumab

Sponsors

Shanghai Cancer Center affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years and = 90 g / L (no blood transfusion within 14 days); Neutrophil count >= 1.5 x 10^9 / L; Platelet count >= 80 x 10^9 / L; (2) Biochemical examination: Total bilirubin = 50 ml / min (Cockcroft Gault formula); 6. Patients who sign informed consent voluntarily; 7. Patients with good compliance, their families are willing to cooperate with survival follow-up. *According to AJCC Cancer staging eighth edition

Exclusion criteria

Exclusion criteria: 1. Patients with other incurable malignant tumors at the same time; 2. Pregnant or lactating women should withdraw from the clinical trial if they are pregnant during the study period; 3. Patients who have participated in clinical trials of other drugs within one month; 4. Patients with known history of other systemic diseases before screening; 5. Patients with long-term unhealed wound or incomplete fracture; 6. Patients with a history of organ transplantation; 7. Patients with abnormal coagulation function (PT > 16S, APTT > 43S, TT > 21s, Patients with bleeding tendency (14 days before randomization: INR was within the normal range without anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients allowed to use low-dose warfarin (1 The dosage of aspirin was less than 100 mg per day; 8. Those patients who had arteriovenous thrombotic events in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, were screened; 9. Patients with a history of psychotropic drug abuse and unable to give up or have mental disorders; 10. Patients with a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or organ transplantation history; 11. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
conversion rate;

Secondary

MeasureTime frame
overall survival;disease control rate;safty;

Countries

China

Contacts

Public ContactLu Wang

Shanghai Cancer Center affiliated to Fudan University

wang.lu99@hotmail.com+86 13601678615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026