Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT05738434
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Cancer by AJCC V8 Stage

Eligibility Criteria

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

Interventions

  • Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib — DRUG
    camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investigator' choice： paclitaxel 135\~150 mg/m2, i.v. d1,q3w; paclitaxel-albumin 150\~180 mg/m2, i.v. d1,q3w. up to 4 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w
  • Camrelizumab+Chemotherapy→Camrelizumab — DRUG
    camrelizumab 200 mg, i.v. d1,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investgator' choice： paclitaxel 175 mg/m2, i.v. d1,q3w; paclitaxel-albumin 200 mg/m2, i.v. d1,q3w up to 6 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w;

Study Details

To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line

Key Dates

Start date
Mar 2, 2023
Status verified
Nov 2024
Primary completion
Sep 1, 2025
Completion
Mar 1, 2027

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Short-course Chemotherapy
  • Active Comparator: Chemotherapy

Primary Outcome Measure

PFS[Progression-Free Survival] [ Time Frame: up to 2 year ]

Central Contacts