Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies
ConditionBiliary Tract Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSir Run Run Shaw Hospital
About this trial
This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.
Eligibility criteria
Qualifiers
Participants who have signed a written Informed Consent Form (ICF);
Male or female participants aged 18-80 years;
Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0/1;
Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment;
Disqualifiers
Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components;
Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy;
History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years;
Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded;
Trial design
Treatments tested in this trial
- Neoadjuvant therapy followed by surgery
Treatment groups
34 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov