SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04146402

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial

The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma

NCT04146402 Head and Neck Squamous Cell Carcinoma
MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Squamous cell carcinoma

2 Interventions

Name: SCT-I10A+chemo

Description: SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU
Type: Drug
Group Labels: 1

SCT-I10A + Chemotherapy

Name: Placebos+chemo

Description: Placebo, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU
Type: Drug
Group Labels: 1

Placebo + Chemotherapy


Primary Outcomes

Description: OS is defined as time from first dose of SCT-I10A until the date of death from any cause

Measure: Overall survival

Time: 1 year

Secondary Outcomes

Description: PFS is defined as the time from first dose of SCT-I10A until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criter

Measure: Progression free survival

Time: 1 year

Description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment

Measure: Objective response rate

Time: 1 year

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 I10A

SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial. --- I10A ---

SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma Overall survival. --- I10A ---

SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma Overall survival. --- I10A --- --- I10A ---

OS is defined as time from first dose of SCT-I10A until the date of death from any cause. --- I10A ---

PFS is defined as the time from first dose of SCT-I10A until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criter. --- I10A ---

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck This is a Phase III, multicenter, randomized, double-blinded trial designed to evaluate Overall survival (OS) of SCT-I10A combined with standard chemotherapy in patients living with Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma --- I10A ---



HPO Nodes


HPO: