A Study of Carilizumab Combined With Concurrent Chemoradiotherapy

Sponsor
Hunan Cancer Hospital
Study ID
NCT05151549
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg/3weeks
  • Cisplatin or Carboplatin — DRUG
    Cisplatin (40mg/m²), every week Carboplatin(AUC 2)

Study Details

This is a one-arm phase II clinical study. In patients with stage III-IVA cervical cancer with pelvic lymph nodes \> 2cm, positive para-aortic lymph nodes, or lymph node metastases \> 2, patients with positive PD-L1 expression (CPS score ≥1) were treated with cararizumab combined with conventional concurrent chemoradiotherapy and immunomaintenance therapy for one year. To evaluate the efficacy and safety of carilizumab in combination with concurrent chemoradiotherapy and subsequent maintenance therapy.

Key Dates

Start date
Dec 1, 2021
Status verified
Nov 2021
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023

Study Design

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

Arms

  • Experimental: Camrelizumab , Cisplatin or Carboplatin
    Participants will be given intravenous administration of Camrelizumab (200mg) ,Cisplatin(40mg/m²) or Carboplatin(AUC 2) and Radiotherapy. After completing 17 cycles of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until one year.

Primary Outcome Measure

2-year PFS rate [ Time Frame: immediately after the concurrent chemoradiation ]

Central Contacts

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