A Study of Sintilimab Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma

Sponsor
Xin-Hua Xu
Study ID
NCT04411706
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab Combined With Apatinib and Capecitabine — DRUG
    Drug: Sintilimab 200mg (3mg/kg for underweight patients) intravenously, every 21 days for a cycle; Drug: Apatinib,250mg po qd, for continuous medication; Drug: Capecitabine,1000mg/m2 po bid, d1-d14, every 21 days for a cycle;

Study Details

This study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.

Key Dates

Start date
Jun 21, 2020
Status verified
Jun 2020
Primary completion
Jun 1, 2021
Completion
Jun 1, 2022

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sintilimab+Apatinib+Capecitabine
    =Drug: Sintilimab（i.v）+apatinib（p.o）+capecitabine（p.o）

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 1 year after the last patient's enrollment ]

Central Contacts

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