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Status unknownNCT05749042Updated Mar 1, 2023

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

A Phase 2 interventional study of Sintilimab and Radiotherapy in Oral Cavity Squamous Cell Carcinoma, sponsored by Xin-Hua Xu. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Xin-Hua Xu · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 70 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Xin-Hua Xu is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
  2. Age ≥18 years, and ≤75years , either sex.
  3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
  4. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
  5. 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).
  6. Initial diagnosis patients unable to perform surgery.
  7. Have at least one measurable lesion as defined by RECIST 1.1.
  8. 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.
  9. Normal renal function :Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
  10. 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].
  11. Has a life expectancy of at ≥3 months.

Exclusion criteria

Exclusion Criteria:

  1. ECOG PS >2.
  2. Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within three months.
  3. Patients who are receiving any other investigational agents within 30 days prior to entering the study.
  4. The tumor has metastasized to the brain and / or pia mater.
  5. 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).
  6. 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.

  7. Those who are allergic to the drug or its components used in the program.
  8. 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.
  9. Those who are not considered suitable for the study by the researchers.
  10. Unwilling to participate in this study or unable to sign informed consent.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Sintilimab+Cisplatin+Radiotherapy

    Drug: Sintilimab

  • Active comparator
    Cisplatin+Radiotherapy

    Radiation: Radiotherapy

Interventions

  • DrugSintilimab

    Concurrent Chemoradiotherapy Based of Cisplatin Plus Sintilimab.

    Also known as: Cisplatin, Radiotherapy

  • RadiationRadiotherapy

    Concurrent Chemoradiotherapy Based of Cisplatin

    Also known as: Cisplatin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: approximately 24 months

  2. 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.

    Time frame: approximately 24 months

Secondary outcomes

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

    Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

    Time frame: approximately 24 months

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

    DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).

    Time frame: approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
    Yichang, Hubei 443003, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05749042
Lead sponsor
Xin-Hua Xu
Responsible party
Xin-Hua Xu (professor, China Three Gorges University, Yichang, China) — Sponsor-investigator
First posted
Mar 1, 2023
Start date
Jan 18, 2023
Primary completion
Jan 18, 2025 (estimated)
Completion
Jan 18, 2025 (estimated)
Last update
Mar 1, 2023

Study contacts

Xinhua Xu, Master
Contact
2732774352@qq.com
+8613986747496 ext. +8613986747496

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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