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

NCT ID: NCT06721286

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative neoadjuvant therapy group

Group Type: EXPERIMENTAL

Teripalimab

Intervention Type: DRUG

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

Gemcitabine + Cisplatin

Intervention Type: DRUG

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

Surgery

Intervention Type: PROCEDURE

Radical resection

Control group

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

Radical resection

Interventions

Teripalimab

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

Intervention Type: DRUG

Gemcitabine + Cisplatin

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

Intervention Type: DRUG

Surgery

Radical resection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18, male or female;

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

2.1 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

3. Can not received systemic treatment before participating in the study;

4. ECOG PS score 0-1;

5. 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.

6. 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.

7. The patient voluntarily participated and signed the informed consent form;

8. 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.

Exclusion Criteria

1. 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);

2. Any other research drugs within 4 weeks before enrollment;

3. 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);

4. Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;

5. 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;

6. 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;

7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

8. Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;

9. 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);

10. Allergic to any test drug;

11. Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;

12. Uncontrollable psychosis;

13. Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Wu

Role: CONTACT

Phone: +86-13821413914

Email: wuqiangtianjin@hotmail.com

Other Identifiers

E20241190

Identifier Type: -

Identifier Source: org_study_id