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

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