Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk

NCT ID: NCT05672537

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2025-12-31

Brief Summary

This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC

Conditions

Durvalumab; Intrahepatic Cholangiocarcinoma; Gemcis

Study Design

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

Study Groups

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

1500mg intravenous injection for 21d cycle

Gemcitabine

Intervention Type: DRUG

gemcitabine 1000mg/m2, D1\&D8, 21d cycle.

Cisplatin

Intervention Type: DRUG

cisplatin 25mg/m2, D1\&D8, 21d cycle.

Surgical treatment group

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

Surgery

Interventions

Durvalumab

1500mg intravenous injection for 21d cycle

Intervention Type: DRUG

Surgery

Surgery

Intervention Type: PROCEDURE

Gemcitabine

gemcitabine 1000mg/m2, D1\&D8, 21d cycle.

Intervention Type: DRUG

Cisplatin

cisplatin 25mg/m2, D1\&D8, 21d cycle.

Intervention Type: DRUG

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
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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

Facility Contacts

Qiang WU, MD. Ph.D.

Role: primary

wuqiangtianjin@hotmail.com

18622221080

Other Identifiers

D20230101

Identifier Type: -

Identifier Source: org_study_id