Clinical trial NCT04295317: PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients with Intrahepatic Cholangiocarcinoma After Surgery
Official title: Eﬀect of PD-1 Antibody (SHR-1210) Combined with Capecitabine Treatment After Resection of Intrahepatic Cholangiocarcinoma with High Risk of Recurrence : a Phase 2 Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: PD-1 Antibody
Capecitabine
Intrahepatic Cholangiocarcinoma
Adjuvant therapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label,single center,non-randomized ,single arm exploratory study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 plus Capecitabine in patients with Intrahepatic Cholangiocarcinoma After Surgery.


Eligibility criteria: Inclusion Criteria:

* age:18-75 years, male or femal;
* Intrahepatic Cholangiocarcinoma confirmed by histopathology, R0 resection was classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA with histolgoic grade G3 according to AJCC TNM (8th edition, 2017);
* No extrahepatic metastases;
* preoperative assessment of Child-Pugh A，ECOG Performance Status 0-1;
* Subjects with chronic HBV infection must have HBV-DNA \<500 IU / ml;
* Functional indicators of vital organs meet the following requirements: Neutrophils ≥1.5\*109/L; platelets≥50\*109/L; hemoglobin≥90g/l; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2.5 times ULN,total bilirubin≤1.5 ULN; International standardized ratio (INR) ≤2.3ULN,creatinine ≤1.5 ULN;
* No tumor recurrence or metastasis was observed.

Exclusion Criteria:

* Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, hilar bile duct cancer;
* No anti-tumor treatment for Intrahepatic Cholangiocarcinoma, including chemotherapy and topical treatment, before surgery;
* Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation;
* Tumors are not completely removed, or postoperative pathology suggests non-Intrahepatic Cholangiocarcinoma or other malignant components;
* Subjects with any active autoimmune disease or history of autoimmune disease;
* Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
* Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
* Received a live vaccine within 4 weeks of the first dose of study medication;
* .Pregnancy or breast feeding;
* Decision of unsuitableness by principal investigator or physician-in- charge.

Primary outcomes:
measure: recurrence-free survival
timeFrame: 24 months
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
measure: the potential side effects
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Zhou, professor
role: PRINCIPAL_INVESTIGATOR
References: