Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs
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|ClinicalTrials.gov Identifier: NCT03311789|
Recruitment Status : Unknown
Verified October 2017 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : October 17, 2017
Last Update Posted : October 17, 2017
This is a single-arm, phase I/II trial in biliary tract cancer (BTC) patients. The purpose of this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with gemcitabine/cisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs.
The primary objective: 6-month progression free survival (PFS). The second objectives: objective clinical response(according to RECIST version 1.1), safety, symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21), overall survival. The exploratory objectives: assessment of immunological response (cytokines, lymphocyte phenotype, immunoglobulins), and evaluation of pathological, immunological and clinical predictive factors for response/toxicity.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: PD-1 inhibitor + Gemcitabine + Cisplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Enrolled patients will be treated with PD-1 inhibitor in combination with gemcitabine/cisplatin chemotherapy.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Experimental: PD-1 inhibitor + Gemcitabine+Cisplatin
Patients will be enrolled in the experimental arm and will receive Gemcitabine on day 1 and 5 (1000mg/m2 ) +Cisplatin on day 1(75mg/m2)+ PD-1 inhibitor on day 3 (Nivolumab 3mg/kg, or SHR-1210 200mg) every 3 weeks. If there is continued benefit after 6 months, PD-1 inhibitor will be administered as maintenance treatment until tumor progression or death.
Drug: PD-1 inhibitor + Gemcitabine + Cisplatin
Gemcitabine: 1000mg/m2 on day 1 and 5 every 3 weeks. Cisplatin: 75mg/m2 on day 1 every 3 weeks. PD-1 inhibitor: Nivolumab 3mg/kg, or SHR-1210 200mg.
Other Name: Nivolumab or SHR-1210
- The percentage of patients alive and without progression at 6 months [ Time Frame: 6 months ]The primary objective of this trial is the progression free survival (PFS) at 6 months in patients with advanced unresectable or metastatic BTCs treated with PD-1 inhibitor in combination with gemcitabine plus cisplatin. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition
- The percentage of patients that respond to combination treatment [ Time Frame: Enrolled patients will be followed until death, withdrawal from study, or until 2 years. ]Overall response rate is defined as the sum of partial responses and complete responses. Partial and complete response will be defined as per irRECIST criteria.
- Median overall survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years. ]The median overall survival (OS) time is defined as the time from enrollment to death.
- List of adverse event frequency and grade [ Time Frame: Up to 120 days after last administration of PD-1 inhibitor ]To evaluate the safety of PD-1 inhibitor in combination with standard chemotherapy in patients with advanced BTCs according to CTCAE 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311789
|Contact: Weidong Han, Ph.Dfirstname.lastname@example.org|
|Contact: Kaichao Feng, MDemail@example.com|
|Study Director:||Weidong Han, Ph.D||Department of Biotherapeutic, Chinese PLA General Hospital|