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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Neoadjuvant therapy followed by surgery
DrugFirst: Envafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W). GC chemotherapy: Gemcitabine: 1000 mg/m2 in 100 mL of 0.9% sodium chloride injection, administered intravenously over 30 minutes on Days 1 and 8, repeated Q3W. Cisplatin: 25 mg/m2 in 500 mL of 5% glucose injection, administered intravenously over 2 hours on Day 1 and 8, repeated Q3W. Of note, no target drugs is involved. Second: Radical resection eligibility will be assessed by the investigator; those with indeterminate resectability require additional MDT discussion confirmation. The criteria for radical resection: 1. No invasion of the main trunk of the hepatic vein, portal vein, or inferior vena cava; 2. No distant metastasis except for hilar lymph node metastases; 3. Minimum distance between surgical margin and tumor border ≥ 0.5 cm; 4. Residual liver volume ≥ 30% (≥ 40% for participants with cirrhosis).
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: GC Chemotherapy Plus Envafolimab ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Pathologic Response (MPR)
MPR is defined as ≤10% residual viable tumor cells in the primary lesion and regional lymph nodes following neoadjuvant therapy, with Pathologic Response Rate (PCR, 0% viable tumor cells) included in the MPR definition.
Time frame
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.Secondary outcomes
1
Residual viable tumor cell ratio
Postoperative resected specimens are analyzed via pathological section to determine the residual viable tumor cell ratio
Time frame
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.2
Objective Response Rate (ORR)
ORR is defined as the sum of Complete Response (CR) and Partial Response (PR), representing the proportion of participants with sustained tumor regression meeting predefined criteria.
Time frame
From enrollment until 2-4 weeks after completion of neoadjuvant therapy (three cycles, each cycle is 21 days)3
Pathologic Response Rate (PCR)
No viable tumor cells are found in the review of pathological sections.
Time frame
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.4
R0 resection
R0 resection rate refers to the proportion of patients achieving complete surgical resection with negative margins.
Time frame
From enrollment to 2-4 weeks after completion of thrid cycles (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.Other outcomes
1
Biomarker Evaluation
Correlations between these biomarkers (including CEA, CA19-9, CA125, spatial transcriptome, and gut microbiome metagenomic sequencing) and overall treatment efficacy, as well as subsequent basic research, are permitted.
Time frame
From enrollment until 2 years after treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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