A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT03736863
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Apatinib+ SHR-1210（Camrelizumab） — DRUG
    Apatinib 250mg, q.d.po+SHR-1210（Camrelizumab）200 mg，Intravenous injection，q2W
  • Apatinib+ SHR-1316（Adebrelimab） — DRUG
    Apatinib 250mg, q.d.po+SHR-1316（Adebrelimab） 1200 mg，Intravenous injection，q2W
  • SHR-1316（Adebrelimab）+SHR-A2009 — DRUG
    SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W,

Study Details

The purpose of this study is to observe and evaluate the efficacy and safety of multiple drug combinations in the treatment of advanced esophageal squamous cell carcinoma.

Key Dates

Start date
Dec 5, 2019
Status verified
Sep 2024
Primary completion
Jun 20, 2021
Completion
Dec 30, 2025

Study Design

Enrollment
147 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CohortA：Apatinib+SHR-1210（Camrelizumab）
    Apatinib+SHR-1210（Camrelizumab）for ESCC who progressed or were intolerant to first-line systemic chemotherapy
  • Experimental: CohortB：Apatinib+SHR-1210（Camrelizumab）
    Apatinib+SHR-1210（Camrelizumab）for ESCC who have failed prior immune checkpoint inhibitor therapies
  • Experimental: CohortC：Apatinib+SHR-1316（Adebrelimab）
    Apatinib+SHR-1316（Adebrelimab）for ESCC who have failed prior immune checkpoint inhibitor therapies
  • Experimental: CohortD：SHR-1316（Adebrelimab）+SHR-A2009
    SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W, for ESCC who have failed prior immune checkpoint inhibitor therapies.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 1 year ]

Central Contacts

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