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

NCT05549466 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)

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.

DRUG

Apatinib, Camrelizumab

Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.

DRUG

Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)

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.

DRUG

Chemotherapy (gemcitabine/ capecitabine/ docetaxel)

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming-yuan Chen, MD, PhD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-08
Primary Completion
2023-09-20
Completion
2025-09-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549466 on ClinicalTrials.gov