A Study of Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients With Advanced Oral Cavity Squamous Cell Carcinoma

NCT05749042 | Unknown Phase 2

• 1 other identifier: CTGU006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of concurrent chemoradiotherapy based of cisplatin with sintilimab as first-line therapy for patients with advanced oral cavity squamous cell carcinoma.

Conditions

Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Compare Progression Free Survival (PFS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.

  PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.

  approximately 24 months

• Compare objective response rate(ORR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.

  ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.

  approximately 24 months

Secondary Outcomes (2)

• Compare Overall Survival (OS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen.

  approximately 24 months

• Compare Disease Control Rate (DCR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.

  approximately 24 months

Study Arms (2)

Sintilimab+Cisplatin+Radiotherapy

EXPERIMENTAL

Drug: Sintilimab

Cisplatin+Radiotherapy

ACTIVE COMPARATOR

Radiation: Radiotherapy

Interventions

Sintilimab DRUG

Concurrent Chemoradiotherapy Based of Cisplatin Plus Sintilimab.

Also known as: Cisplatin, Radiotherapy

Sintilimab+Cisplatin+Radiotherapy

Radiotherapy RADIATION

Concurrent Chemoradiotherapy Based of Cisplatin

Also known as: Cisplatin

Cisplatin+Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
• Age ≥18 years, and ≤75years , either sex.
• Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
• Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
• Patients with oral squamous cell carcinoma (including gingival cancer, tongue cancer, lip cancer, buccal cancer, oral cancer, etc) diagnosed by histopathology (according to the 8th edition of AJCC).
• Initial diagnosis patients unable to perform surgery.
• Have at least one measurable lesion as defined by RECIST 1.1.
• Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present.
• Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
• Normal hematological function：absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\].
• Has a life expectancy of at ≥3 months.

You may not qualify if:

• ECOG PS \>2.
• Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within three months.
• Patients who are receiving any other investigational agents within 30 days prior to entering the study.
• The tumor has metastasized to the brain and / or pia mater.
• History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years).
• Accompanied by other serious diseases, including but not limited to:
• Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP \> 160mmhg or DBP \> 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance.
• Those who are allergic to the drug or its components used in the program.
• Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
• Those who are not considered suitable for the study by the researchers.
• Unwilling to participate in this study or unable to sign informed consent.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, Hubei, 443003, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

sintilimab; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Central Study Contacts

Xinhua Xu, Master

CONTACT

+8613986747496; 2732774352@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: January 18, 2023
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)