CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 84 target
Drug / intervention
Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) +3 moredrug
Likely dose
Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05549466
NCT05549466Phase 2Unknown

Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

Sun Yat-sen University·interventional·Posted Sep 22, 2022·Updated Feb 8, 2023

In Brief

A Phase 2 clinical trial evaluating Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Apatinib, Camrelizumab, and 2 other interventions for Nasopharyngeal Carcinoma. Targeting 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2023202420252026
First PostedSep 22, 2022
Enrollment StartOct 8, 2022
Primary CompletionSep 20, 2023
Study CompletionSep 20, 2025
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 3.8 years ago

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, Camrelizumabdrug

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.