- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634058
PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment
PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment: a Single-arm, Phase II Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital
-
Contact:
- Huang xiaoyong
-
Shanghai, China, 200032
- Not yet recruiting
- Zhongshan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) For unresectable or metastatic or postoperative recurrence, histologically confirmed advanced ICC, provide enough tissue samples for PD-L1, CTLA-4 immunohistochemistry, and exome sequencing 2) The standard systemic treatment of advanced ICC (gemcitabine or platinum or fluorouracil) failed due to disease progression or toxicity 3) There are measurable lesions defined by RECIST standard v1.1 4) For patients with a history of liver chemoembolization, radiofrequency ablation/intervention, or radiotherapy, there must be measurable lesions outside the chemoembolization or radiotherapy area or measurable progression lesions at the chemoembolization or radiotherapy site 5) ECOG physical strength status ≤ 1 6) Life expectancy> 3 months 7) Adequate renal function: creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or glomerular filtration rate (GFR) ≥ 60mL/min/1.73 m2 8) Sufficient liver function: bilirubin ≤ 1.5 × ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN 9) Sufficient bone marrow reserve: absolute value of neutrophils (ANC)> 1500/mcl, platelets (Plts)> 75,000/mcl, hemoglobin (Hgb) ≥ 9.0g/dl 10) Prothrombin time/activated partial thromboplastin time (PT/PTT) <1.5 × ULN 11) Age ≥18 years old 12) HBV infected persons must meet the following criteria to be eligible to participate in the study: Chronic hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg] positive and/or detectable HBV DNA) subjects must have HBV viral load below 2000 IU/ml before the first dose of the study intervention. Active HBV-treated subjects with a viral load of less than 2000 IU/ml should receive antiviral therapy throughout the study intervention period and check the HBV viral load every 6 weeks. Subjects whose HBV infection is clinically cured (defined as HBsAg negative and anti-HBc positive) and whose HBV viral load cannot be detected during screening should be checked for HBV viral load every 6 weeks. If the viral load exceeds 2000 IU/ml, HBV treatment should be carried out. Antiviral treatment after completing the research intervention should follow local guidelines.
13) The toxicity of the previous treatment has been restored to ≤1 grade (if there is surgery, the wound has completely healed) 14) Female subjects of childbearing age must undergo a pregnancy test within 2 weeks before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraceptive method during the study period and within 24 weeks after the last study drug administration (Such as intrauterine device, contraceptive pills or condoms); for male subjects whose partners are females of childbearing age, they should agree to use effective methods of contraception during the study period and within 24 weeks after the last study administration 15) Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
1) Past treatment with PD-L1 mAb, CTLA-4 mAb 2) Hilar cholangiocarcinoma or extrahepatic cholangiocarcinoma or periampullary carcinoma or gallbladder cancer 3) Major surgery or radiotherapy within 4 weeks before enrollment 4) Active, known, or suspected autoimmune diseases 5) Congestive heart failure or symptomatic coronary artery disease within 3 months before enrollment 6) Cerebrovascular accident occurred in the past 6 months 7) Clinically significant bleeding, bleeding event, or thromboembolic disease occurred within 6 months 8) History of bowel perforation 9) A history of (non-infectious) pneumonia requiring steroid treatment or current pneumonia 10) Known history of human immunodeficiency virus (HIV) infection 11) History of severely impaired lung function or interstitial lung disease 12) Diagnosed concurrent malignant tumors in the past 5 years (except for fully treated non-melanoma skin cancer, superficial transitional cell carcinoma of the bladder and cervical carcinoma in situ [CIS]) or any currently active malignant tumors 13) HCV RNA positive test indicates the active period 14) Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation 15) Uncontrollable or symptomatic hypercalcemia 16) Known uncontrollable or symptomatic active central nervous system (CNS) metastasis 17) Symptomatic advanced patients who are at risk of life-threatening complications in the short term (including patients with uncontrollable large amounts of exudate [thoracic cavity, pericardium, abdominal cavity]) 18) Known allergies to study drugs or excipients or known severe allergic reactions to any monoclonal antibody 19) Severe infections during screening, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.
20) Have received any other experimental drug treatment or participated in another interventional clinical study within 4 weeks before signing the ICF 21) Live attenuated vaccine within 4 weeks before enrollment or planned during the study period and 60 days after the end of study drug treatment 22) Known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse, etc.
23) Past or current evidence indicates that any conditions, treatments, or laboratory abnormalities that may confuse the research results, interfere with the subject's participation in the entire research process, or the researcher believes that participating in this research is not in the subjects' best interests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PD-L1 antibody combined with CTLA-4 antibody
After 4 cycles of PD-L1 antibody combined with CTLA-4 antibody treatment, PD-L1 monotherapy was maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
|
After 4 cycles of PD-L1 monoclonal antibody combined with CTLA-4 monoclonal antibody treatment, PD-L1 monotherapy was maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate (ORR)
Time Frame: 12 months
|
the objective response rate (ORR) of advanced ICC patients who progressed after standard treatment with PD-L1 antibody SHR-1316 combined with CTLA-4 antibody IBI310
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: the potential side effects
Time Frame: 12 months
|
the potiential side effects
|
12 months
|
overall survival
Time Frame: 18 months
|
From the beginning date of combined therapy to the date of death
|
18 months
|
Progression free survival
Time Frame: 12 months
|
From the beginning date of combined therapy to disease progresion or death, whichever occurs first
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lu JC, Zeng HY, Sun QM, Meng QN, Huang XY, Zhang PF, Yang X, Peng R, Gao C, Wei CY, Shen YH, Cai JB, Dong RZ, Shi YH, Sun HC, Shi YG, Zhou J, Fan J, Ke AW, Yang LX, Shi GM. Distinct PD-L1/PD1 Profiles and Clinical Implications in Intrahepatic Cholangiocarcinoma Patients with Different Risk Factors. Theranostics. 2019 Jul 9;9(16):4678-4687. doi: 10.7150/thno.36276. eCollection 2019.
- Lim YJ, Koh J, Kim K, Chie EK, Kim S, Lee KB, Jang JY, Kim SW, Oh DY, Bang YJ. Clinical Implications of Cytotoxic T Lymphocyte Antigen-4 Expression on Tumor Cells and Tumor-Infiltrating Lymphocytes in Extrahepatic Bile Duct Cancer Patients Undergoing Surgery Plus Adjuvant Chemoradiotherapy. Target Oncol. 2017 Apr;12(2):211-218. doi: 10.1007/s11523-016-0474-1.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zs-ICC-PDCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholangiocarcinoma, Intrahepatic
-
M.D. Anderson Cancer CenterActive, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic CholangiocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic Cholangiocarcinoma | Oligometastatic Intrahepatic CholangiocarcinomaUnited States
-
Emory UniversityNational Cancer Institute (NCI)WithdrawnStage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Resectable Intrahepatic Cholangiocarcinoma | Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 | Stage I Intrahepatic Cholangiocarcinoma AJCC v8United States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH); CelgeneActive, not recruitingResectable Cholangiocarcinoma | Stage IB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8United States
-
Massachusetts General HospitalTerminatedResectable Intrahepatic Cholangiocarcinoma | Unresectable Intrahepatic CholangiocarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityActive, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Liver and Intrahepatic Bile Duct Carcinoma | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic CholangiocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Gallbladder Carcinoma | Metastatic Cholangiocarcinoma | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable CholangiocarcinomaUnited States
-
NRG OncologyNational Cancer Institute (NCI)TerminatedStage III Intrahepatic Cholangiocarcinoma | Stage IVA Intrahepatic CholangiocarcinomaUnited States, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnBile Duct Adenocarcinoma | Stage III Intrahepatic Cholangiocarcinoma | Stage IVA Intrahepatic Cholangiocarcinoma | Stage IVB Intrahepatic CholangiocarcinomaUnited States
-
Shanghai Zhongshan HospitalUnknownCholangiocarcinoma, IntrahepaticChina
Clinical Trials on PD-L1 antibody combined with CTLA-4 antibody
-
Northwestern UniversityNational Cancer Institute (NCI)RecruitingLocally Advanced Thyroid Gland Anaplastic Carcinoma | Metastatic Thyroid Gland Anaplastic Carcinoma | Metastatic Thyroid Gland Oncocytic CarcinomaUnited States
-
Shanghai Zhongshan HospitalRecruitingOesophageal Squamous Cell CarcinomaChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Agenus Inc.; Dutch Cancer SocietyNot yet recruiting
-
Innovent Biologics (Suzhou) Co. Ltd.Active, not recruiting
-
Dragonboat Biopharmaceutical Company LimitedWest China HospitalRecruitingAdvanced Malignant TumorChina
-
Tongji HospitalNational Natural Science Foundation of ChinaRecruitingEsophageal Squamous Cell Carcinoma | Neoadjuvant TherapiesChina
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Tianjin Medical University Cancer Institute and...RecruitingLocally Advanced Gastric AdenocarcinomaChina
-
Xiangya Hospital of Central South UniversityActive, not recruiting
-
LiuYingNot yet recruitingColorectal Cancer | Neoadjuvant Therapy | Mismatch Repair-deficient (dMMR) | Microsatellite Instability-high (MSI-H)China