Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18, male or female;

• Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:

⁃ 1 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.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Qiang Wu
wuqiangtianjin@hotmail.com
+86-13821413914
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 70
Treatments
Experimental: Preoperative neoadjuvant therapy group
Experimental: Control group
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov