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Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of R/M HNSCC.

NCT04882462 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-12

No results posted yet for this study

Summary

This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The main endpoint is progression free survival (PFS); the secondary endpoint are objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.

Conditions

  • Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Nimotuzumab

Nimotuzumab, 400mg, intravenously every 3 weeks, for at least 18 weeks

DRUG

Sintilimab

Sintilimab, 200mg, intravenously every 3 weeks, for at least 18 weeks;

DRUG

Chemotherapy drug

Chemotherapy drugs were selected by the investigator, every 3 weeks, for 18 weeks

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    collaborator OTHER

  • Cinda Biopharmaceutical (Suzhou) Co., Ltd.

    collaborator UNKNOWN

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2021-11-30
Completion
2022-12-31

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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 NCT04882462 on ClinicalTrials.gov