Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

Sponsor
Sun Yat-sen University
Study ID
NCT05549466
Phase
PHASE2
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) — DRUG
    Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
  • Apatinib, Camrelizumab — DRUG
    Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
  • Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) — DRUG
    Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Camrelizumab, iv, 200mg, D1, Q3W.
  • Chemotherapy (gemcitabine/ capecitabine/ docetaxel) — DRUG
    Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W.

Study Details

Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. Based on previous clinical trials, anti-angiogenic drugs combined with immunotherapy were found to be effective. Therefore, this study intends to preliminarily evaluate which treatment regimen can provide the most benefit to PD-1 inhibitor refractory patients by comparing the efficacy of VEGFR inhibitor or standard chemotherapy combined with PD-1 inhibitor.

Key Dates

Start date
Oct 8, 2022
Status verified
Feb 2023
Primary completion
Sep 20, 2023
Completion
Sep 20, 2025

Study Design

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

Arms

  • Experimental: Apatinib plus Camrelizumab and Chemotherapy
  • Experimental: Apatinib plus Camrelizumab
  • Experimental: Camrelizumab and Chemotherapy
  • Active Comparator: Chemotherapy

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 1 year ]

Central Contacts

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