Trial · NCT07457099
Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
NCT07457099, Not yet recruiting, Zhujiang Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma. Trials, record NCT07457099. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07457099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
- NCT number
- NCT07457099
- Status
- Not yet recruiting
- Enrollment
- 85 participants, estimated
- Lead sponsor
- Zhujiang Hospital
- Conditions
- Locally Advanced Oral Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Interventions
- Observation, Postoperative Radiotherapy, PD-1 Inhibitor Maintenance Therapy
- First posted
- 2026-03-09
- Last updated
- 2026-03-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-Year Event-Free Survival (EFS) | 1-Year | Time from the date of radical surgery to the first occurrence of disease recurrence (local, regional, or distant), disease progression, death from any cause, or last follow-up, whichever occurs first. |
| Primary | Pathological Complete Response (pCR) Rate | At the time of surgery | Pathological complete response (pCR) is defined as the absence of residual viable tumor cells in both the primary tumor site and all resected lymph nodes, as assessed by postoperative histopathological examination. |
| Secondary | 1-Year Overall Survival (OS) | 1-Year | Time from the date of surgery to death from any cause or last follow-up. |
| Secondary | Major Pathological Response (MPR) Rate | At the time of surgery | Major pathological response is defined as ≤10% residual viable tumor cells in the surgical specimen, as determined by histopathological evaluation |
| Secondary | Failure Patterns | 1-Year | Distribution of recurrence events categorized as local, regional, or distant. |
| Secondary | Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC) | 1-Year | The incidence of grade 3 or higher radiotherapy-related toxicities, assessed according to the Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria. Toxicity grades range from Grade 0 (no toxicity) to Grade 5 (death related to toxicity), with higher grades indicating more severe toxicity. |
| Secondary | Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0) | 1-Year | The incidence of grade 3 or higher immunotherapy-related adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Adverse event grades range from Grade 1 (mild) to Grade 5 (death related to adverse events), with higher grades indicating more severe toxicity. |
| Secondary | Swallowing Function | 1-Year | Swallowing function was assessed based on clinically documented swallowing evaluations during follow-up visits, including physician-reported functional assessments. Functional status was categorized according to institutional clinical practice, with higher functional levels indicating better swallowing ability. |
| Secondary | Nutritional Status Assessed by NRS-2002 Score | 1-Year | Nutritional status was assessed using the Nutritional Risk Screening 2002 (NRS-2002) score. The NRS-2002 score ranges from 0 to 7, with higher scores indicating greater nutritional risk. |
| Secondary | Quality of Life (Clinically Documented Functional Assessment) | 1-Year | Quality of life was assessed based on clinically documented functional assessments recorded during routine follow-up visits. Evaluations focused on patient-reported symptoms and functional status related to daily activities. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07457099
GET https://conductscience.org/api/trials/v1/NCT07457099/registered