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Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis

NCT04104074 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-07

No results posted yet for this study

Summary

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

Conditions

Interventions

RADIATION

Radiotherapy

Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.

DRUG

Sintilimab

Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks

Sponsors & Collaborators

  • Beijing Tsinghua Chang Gung Hospital

    lead OTHER

Principal Investigators

  • Gong Li, MD · Beijing Tsinghua Changgeng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104074 on ClinicalTrials.gov