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

NCT05672537 | Unknown Phase 2

• 1 other identifier: D20230101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 1-year relapse free survival rate

  1-year

Secondary Outcomes (8)

• 2-year relapse free survival rate

  2-year

• ORR

  1-year

• DCR

  1-year

• R0 resection rate

  1-year

• 30 day postoperative complication rate

  30 day

Study Arms (2)

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

EXPERIMENTAL

Drug: Durvalumab; Drug: Gemcitabine; Drug: Cisplatin

Surgical treatment group

EXPERIMENTAL

Procedure: Surgery

Interventions

Durvalumab DRUG

1500mg intravenous injection for 21d cycle

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

Surgery PROCEDURE

Surgery

Surgical treatment group

Gemcitabine DRUG

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

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

Cisplatin DRUG

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

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• 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

Interventions

durvalumab; Surgical Procedures, Operative; Gemcitabine; Cisplatin

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

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: January 3, 2023
• First Posted: January 5, 2023
• Study Start: January 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

CN (1)