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Trial Title:
Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk
NCT ID:
NCT05672537
Condition:
Durvalumab
Intrahepatic Cholangiocarcinoma
Gemcis
Conditions: Official terms:
Cholangiocarcinoma
Recurrence
Gemcitabine
Durvalumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
1500mg intravenous injection for 21d cycle
Arm group label:
Durvalumab Combined with GemCis Neoadjuvant Therapy Group
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery
Arm group label:
Surgical treatment group
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
gemcitabine 1000mg/m2, D1&D8, 21d cycle.
Arm group label:
Durvalumab Combined with GemCis Neoadjuvant Therapy Group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
cisplatin 25mg/m2, D1&D8, 21d cycle.
Arm group label:
Durvalumab Combined with GemCis Neoadjuvant Therapy Group
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang WU, MD. Ph.D.
Phone:
18622221080
Email:
wuqiangtianjin@hotmail.com
Investigator:
Last name:
Qiang WU, MD. Ph.D.
Email:
Principal Investigator
Start date:
January 20, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672537
