SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT03816553
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Cervical Cancer
  • Recurrent Cervical Carcinoma

Eligibility Criteria

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

Interventions

  • SHR-1210 — DRUG
    SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg (3mg/kg for underweight patients).
  • Apatinib — DRUG
    Apatinib will be administered 250mg orally, once daily until progression.

Study Details

The purpose of this study is to explore the efficacy and safety of SHR-1210 in combination with apatinib in treating patients with metastatic, persistent, or recurrent cervical cancer.

Key Dates

Start date
Jan 19, 2019
Status verified
Apr 2023
Primary completion
Apr 30, 2020
Completion
Aug 31, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210 + Apatinib
    Participants receive SHR-1210 200mg (3mg/kg for underweight patients) intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]

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