Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma (NEOPBOSCC)
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|ClinicalTrials.gov Identifier: NCT04649476|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Oral Squamous Cell Carcinoma||Drug: Camrelizumab Drug: Camrelizumanb plus TPF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Neoadjuvant PD-1 Blockade Alone or Plus TPF Induction Chemotherapy for Resectable Local Advanced Oral Squamous Cell Carcinoma|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Neoadjuvant PD-1 blockade alone
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
Other Name: SHR-1210
Experimental: Neoadjuvant PD-1 blockade plus TPF induction chemotherapy
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Drug: Camrelizumanb plus TPF
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.
Other Name: Docetaxel, Cisplatin, 5-Fluorouracil
- Pathologic response. [ Time Frame: 8 weeks. ]Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. The rate of major pathologic response, defined as <10% residual viable tumor cells in the resected specimen.
- Radiographic response. [ Time Frame: 8 weeks. ]Clinical response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy, as evaluated by radiographic examinations and defined by RECIST 1.1.
- Event-free survival (EFS) rate on each treatment arm. [ Time Frame: 24 months. ]EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.
- Overall survival (OS) on each treatment arm. [ Time Frame: 24 months. ]OS is the time from randomization to death due to any cause.
- Adverse events (AEs). [ Time Frame: 24 months. ]Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions.
- Changes in the level of circualting exosomal PD-L1. [ Time Frame: 24 months. ]The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649476
|Contact: Gang Chen, M.D.||+86 email@example.com|
|Hospital of Stomatology, Wuhan University|
|Wuhan, Hubei, China, 430079|
|Contact: Gang Chen, M.D. +86 02787686215 firstname.lastname@example.org|
|Principal Investigator:||Gang Chen, MD||Hospital of Stomatology, Wuhan University|