Trial · NCT07371611
Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma
NCT07371611, Phase 3, Recruiting, Qunxing Li,MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma. Trials, record NCT07371611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07371611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma
- NCT number
- NCT07371611
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 104 participants, estimated
- Lead sponsor
- Qunxing Li,MD
- Conditions
- Locally Advanced Oral Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma (OSCC)
- Interventions
- Sintilimab plus nab-paclitaxel and platinum-based chemotherapy, Radical surgery combined with radiotherapy or chemoradiotherapy
- First posted
- 2026-01-28
- Last updated
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | 2 years | Event-free survival is defined as the time from randomization to the first occurrence of disease progression, local or distant recurrence, second primary malignancy, or death from any cause, whichever occurs first. |
| Secondary | overall survival（OS） | 2 years and 5 years. | Overall survival (OS) was defined as the time from randomization to death from any cause. |
| Secondary | pathological complete response（pCR） | At the time of definitive surgery | Pathological complete response (pCR) is defined as the absence of residual viable tumor cells on microscopic examination in the resected primary tumor and lymph nodes, with all evaluated lymph nodes being negative. The pCR rate is calculated as the proportion of participants achieving pCR among all enrolled participants. The pCR rate is expressed as a percentage and its 95% confidence interval is estimated using the exact binomial distribution. |
| Secondary | Major Pathological Response (MPR) | At the time of definitive surgery | Major pathological response (MPR) is defined as the presence of 10% or less residual viable tumor cells in the resected primary tumor specimen on microscopic examination after neoadjuvant treatment, regardless of lymph node status. The MPR rate is calculated as the proportion of participants achieving MPR among all enrolled participants. The MPR rate is expressed as a percentage and its 95% confidence interval is estimated using the exact binomial distribution. |
| Secondary | Treatment-related adverse events（TRAE） | through study completion, an average of 1 year | Treatment-related adverse events (TRAEs) are defined as adverse events that are considered by the investigator to be possibly, probably, or definitely related to the study treatment, including sintilimab, chemotherapy, surgery, radiotherapy, or chemoradiotherapy. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. The incidence, severity, and type of TRAEs will be summarized and analyzed. |
| Secondary | Radiologic assessments | Baseline and preoperative | Radiologic assessments are performed to evaluate tumor response using contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). Tumor response is assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, based on independent radiologic review. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40532178 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07371611
GET https://conductscience.org/api/trials/v1/NCT07371611/registered