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PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients With Intrahepatic Cholangiocarcinoma After Surgery

Primary Purpose

Intrahepatic Cholangiocarcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PD-1 blocking antibody SHR-1210

Capecitabine

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring PD-1 Antibody, Capecitabine, Intrahepatic Cholangiocarcinoma, Adjuvant therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined the therapy using Capecitabine and PD-1

Arm Description

PD1 antibody SHR-1210 D1 200 mg every three weeks; Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis) Capecitabine 2500mg / m2, 2 times/d for 2 weeks, followed by 1 week of stopping ,Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)

Outcomes

Primary Outcome Measures

recurrence-free survival

From the date of liver surgery to the date of diagnosis of tumor recurrence

Secondary Outcome Measures

overall survival

From the date of liver surgery to the date of death

the potential side effects

Full Information

NCT ID

NCT04295317

First Posted

March 2, 2020

Last Updated

September 26, 2020

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04295317

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrahepatic Cholangiocarcinoma

Keywords

PD-1 Antibody, Capecitabine, Intrahepatic Cholangiocarcinoma, Adjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined the therapy using Capecitabine and PD-1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PD-1 blocking antibody SHR-1210

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine 2500mg / m2/ d, 2 times/d for 2 weeks, followed by 1 week of stopping ,Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)

Primary Outcome Measure Information:

Title

recurrence-free survival

Description

From the date of liver surgery to the date of diagnosis of tumor recurrence

Time Frame

24 months

Secondary Outcome Measure Information:

Title

overall survival

Description

From the date of liver surgery to the date of death

Time Frame

24 months

Title

the potential side effects

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Zhou, professor

Phone

0086-21-64041990

zhou.jian@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zheng Wang, professor

Phone

0086-21-64041990

wzdoc@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Zhou, professor

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

180 Fenglin Road

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Zhou, professor

Phone

0086-21-64041990

zhou.jian@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Zheng Wang, professor

Phone

0086-21-64041990

wzdoc@163.com

First Name & Middle Initial & Last Name & Degree

Jian Zhou, professor

First Name & Middle Initial & Last Name & Degree

Zheng Wang, professor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients With Intrahepatic Cholangiocarcinoma After Surgery

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