Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma

NCT06721286 | Recruiting Phase 2

• 1 other identifier: E20241190
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

Intrahepatic Cholangiocarcinoma; neoadjuvant therapy; toripalimab

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence-free survival rate

  1 year

Secondary Outcomes (7)

• 1-year OS

  1 year

• 2-year OS

  2-year

• ORR

  1 year

• DCR

  1 year

• R0 resection rate

  1 year

Study Arms (2)

Preoperative neoadjuvant therapy group

EXPERIMENTAL

Drug: Teripalimab; Drug: Gemcitabine + Cisplatin; Procedure: Surgery

Control group

EXPERIMENTAL

Procedure: Surgery

Interventions

Teripalimab DRUG

240mg intravenous injection, D1, q3w, for 9 weeks (3 cycles)

Preoperative neoadjuvant therapy group

Gemcitabine + Cisplatin DRUG

Gemcitabine 1000mg/m2 + cisplatin 25mg/m2, D1\&D8, q3w, for 9 weeks (3 cycles)

Preoperative neoadjuvant therapy group

Surgery PROCEDURE

Radical resection

Control group; Preoperative neoadjuvant therapy group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18, male or female;
• Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:
• Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
• Can not received systemic treatment before participating in the study;
• ECOG PS score 0-1;
• The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
• Laboratory inspection shall meet the following requirements:
• Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.
• The patient voluntarily participated and signed the informed consent form;
• It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the requirements of the scheme.

You may not qualify if:

• Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
• Any other research drugs within 4 weeks before enrollment;
• Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
• Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
• Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
• Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during screening/before the first drug administration;
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;
• Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
• Allergic to any test drug;
• Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;
• Uncontrollable psychosis;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

Gemcitabine; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Qiang Wu

CONTACT

+86-13821413914; wuqiangtianjin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-10

Locations

CN (1)