Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Advanced Esophageal Squamous Cell Cancer

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05322499
Phase
PHASE2
Status
Unknown

Conditions

  • Stage IV Esophagus Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    200mg/dose intravenous infusion, D1, once every 3 weeks (q3w);
  • Irinotecan — DRUG
    100-125mg/m2，d1，d8；q21d
  • Paclitaxel — DRUG
    135-175mg/m2，d1，Q3W
  • Paclitaxel-albumin — DRUG
    100-135mg/m2, d1、d8，Q3W
  • Docetaxel — DRUG
    60-75mg/m2，d1，Q3W
  • Anlotinib — DRUG
    12mg，qd，d1-d14，q3w

Study Details

To observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy

Key Dates

First listed
Apr 11, 2022
Start date
Apr 15, 2022
Status verified
Apr 2022
Primary completion
Apr 15, 2023
Completion
Apr 15, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combined chemotherapy group
    Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Chemotherapy (considered by investigator on a patient-by-patient basis): Irinotecan: 100-125mg/m2, d1, d8; q21d; Paclitaxel: 135-175mg/m2, d1, Q3W; Docetaxel: 60-75mg/m2, d1, Q3W Albumin paclitaxel: 100-135mg/m2, d1, d8, Q3W. Treat until disease progression or intolerable toxicity
  • Experimental: Combined anlotinib group
    Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Anlotinib: 12mg, qd, d1-d14, q3w; Treat until disease progression or intolerable toxicity.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 24 month ]

Central Contacts