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

Primary Purpose

Durvalumab, Intrahepatic Cholangiocarcinoma, Gemcis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Durvalumab
Surgery
Gemcitabine
Cisplatin
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Durvalumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18, male or female; 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 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Durvalumab Combined with GemCis Neoadjuvant Therapy Group

Surgical treatment group

Arm Description

Outcomes

Primary Outcome Measures

1-year relapse free survival rate

Secondary Outcome Measures

2-year relapse free survival rate
ORR
DCR
R0 resection rate
30 day postoperative complication rate
Occurrence of adverse reactions
1-year OS
2-year OS

Full Information

First Posted
January 3, 2023
Last Updated
January 3, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05672537
Brief Title
Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk
Official Title
Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Durvalumab, Intrahepatic Cholangiocarcinoma, Gemcis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab Combined with GemCis Neoadjuvant Therapy Group
Arm Type
Experimental
Arm Title
Surgical treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
1500mg intravenous injection for 21d cycle
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
gemcitabine 1000mg/m2, D1&D8, 21d cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
cisplatin 25mg/m2, D1&D8, 21d cycle.
Primary Outcome Measure Information:
Title
1-year relapse free survival rate
Time Frame
1-year
Secondary Outcome Measure Information:
Title
2-year relapse free survival rate
Time Frame
2-year
Title
ORR
Time Frame
1-year
Title
DCR
Time Frame
1-year
Title
R0 resection rate
Time Frame
1-year
Title
30 day postoperative complication rate
Time Frame
30 day
Title
Occurrence of adverse reactions
Time Frame
1-year
Title
1-year OS
Time Frame
1-year
Title
2-year OS
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18, male or female; 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 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. Exclusion Criteria: 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; 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.
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang WU, MD. Ph.D.
Phone
18622221080
Email
wuqiangtianjin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qiang WU, MD. Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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