Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer

NCT05978609 | Recruiting Phase 2

• 1 other identifier: 2023-1036
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:

• Is this combined treatment protocol safe for these patients?
• Is this combined treatment protocol effective in treating these patients? Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.

Conditions

Cholangiocarcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  through study completion, an average of 1 year

Other Outcomes (2)

• overall survival (OS)

  through study completion, an average of 1 year

• progression free survival (PFS)

  through study completion, an average of 1 year

Study Arms (1)

Candonilimab in combination with cisplatin and gemcitabine

EXPERIMENTAL

This study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Drug: Candonilimab; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Candonilimab DRUG

Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Candonilimab in combination with cisplatin and gemcitabine

Cisplatin DRUG

Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Candonilimab in combination with cisplatin and gemcitabine

Gemcitabine DRUG

gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Candonilimab in combination with cisplatin and gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtain written informed consent before implementing any experimental procedures.
• Age between 18 and 75 years (any gender).
• Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma).
• No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the past 6 months.
• Expected survival time \> 3 months.
• Presence of at least one measurable lesion according to RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
• Adequate organ function, with the following laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L, without the use of granulocyte-colony stimulating factor in the past 14 days.
• Platelet count ≥ 90x10\^9/L, without transfusion in the past 14 days.
• Hemoglobin \> 9 g/dL, without transfusion or use of erythropoietin-stimulating agents in the past 14 days.
• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN for patients with liver metastases).
• Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml/min.
• Coagulation function within normal limits, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.

You may not qualify if:

• Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma within the past 5 years.
• Tumors located in the ampulla of Vater.
• Currently participating in an interventional clinical study or received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose of study drug.
• Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g., CTLA-4, OX-40, CD137).
• Previously received palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy.
• Received traditional Chinese medicine or immune modulatory drugs with anti-tumor indications within 2 weeks prior to the first dose of study drug (including thymosin, interferon, interleukins), except for local use to control pleural effusion.
• Active autoimmune diseases requiring systemic treatment within 2 years prior to the first dose of study drug, or known history of primary immunodeficiency diseases. Patients with positive autoimmune antibodies alone will be evaluated by the investigator to determine if they have autoimmune diseases.
• Currently receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or topical corticosteroids) or any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug. Physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted.
• Uncontrolled pleural effusion or ascites that requires drainage or has not shown a significant increase in the past 3 days in patients who do not require drainage or whose drainage has been stopped.
• Prior solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to the study drug, Candonilimab active substance, or excipients.
• Insufficient recovery from any toxicities and/or complications related to previous interventions before starting treatment (i.e., ≤ Grade 1 or returning to baseline, excluding fatigue or alopecia).
• Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies).
• Untreated active hepatitis B defined as positive HBsAg and detectable HBV-DNA levels above the upper limit of normal at the study center. Note: The following HBV-infected patients may be included:
• HBV viral load \<2.5 × 10\^3 copies/mL (500 IU/mL) prior to the first dose of study drug, and patients should receive anti-HBV therapy throughout the study treatment.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

Cisplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Tao Wang

CONTACT

17844623533; wangshoutao1219@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 7, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

CN (1)