CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Camrelizumab +1 moredrug
Likely dose
Camrelizumab 200 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/NCT04649476
NCT04649476Phase 2Completed

A Randomized Phase II Study of Neoadjuvant PD-1 Blockade Alone or Plus TPF Induction Chemotherapy for Resectable Local Advanced Oral Squamous Cell Carcinoma

Hospital of Stomatology, Wuhan University·interventional·Posted Dec 2, 2020·Updated Jan 10, 2025

In Brief

A Phase 2 clinical trial evaluating Camrelizumab and Camrelizumanb plus TPF for Oral Squamous Cell Carcinoma. Completed, enrolled 68 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.

Study Details

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

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 2, 2020
Enrollment StartMar 22, 2021
Primary CompletionAug 10, 2022
Study CompletionAug 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago

Interventions

Camrelizumabdrug

The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.

Camrelizumanb plus TPFdrug

The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.