Trial · NCT07492914
Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
NCT07492914, Phase 2, Recruiting, West China Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma. Trials, record NCT07492914. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07492914
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
- NCT number
- NCT07492914
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- West China Hospital
- Conditions
- Resectable Head and Neck Squamous Cell Carcinoma
- Interventions
- Sacituzumab Govitecan, Tagitanlimab
- First posted
- 2026-03-25
- Last updated
- 2026-05-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Pathological Response Rate (MPR) | Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy) | Major Pathological Response Rate (MPR) is defined as the proportion of enrolled patients with residual viable tumor (RVT) ≤10% in the primary tumor and regional lymph node resection specimens after completion of 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per immune-related pathological response criteria (irPRC) by independent pathological reviewers. MPR is the primary efficacy endpoint to evaluate the anti-tumor activity of the combined neoadjuvant regimen in resectable head and neck squamous cell carcinoma (HNSCC). |
| Secondary | Objective Response Rate (ORR) | Assessed at 3 to 6 weeks after the completion of neoadjuvant therapy (prior to surgical resection) | Objective Response Rate (ORR) is defined as the proportion of enrolled patients achieving a confirmed complete response (CR) or partial response (PR) in tumor lesions after 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent radiological reviewers. ORR reflects the short-term anti-tumor efficacy of the combined neoadjuvant regimen on measurable HNSCC lesions. |
| Secondary | Event-Free Survival (EFS) | Assessed up to 2 years after the first dose of neoadjuvant therapy (with regular follow-up every 3-4 months) | Event-Free Survival (EFS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to the first occurrence of any study event, including radiologically or pathologically confirmed disease progression, local/distant tumor recurrence, or all-cause mortality. EFS evaluates the medium-term disease control efficacy of the combined regimen in resectable HNSCC patients. |
| Secondary | Overall Survival (OS) | Assessed up to 5 years after the first dose of neoadjuvant therapy (follow-up every 6 months for years 3-5, annually after year 5) | Overall Survival (OS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to all-cause mortality in enrolled patients. OS is a key endpoint reflecting the long-term survival benefit of the combined neoadjuvant regimen for resectable HNSCC patients, with survival status monitored through regular clinical follow-up. |
| Secondary | Incidence and Severity of Treatment-Related Adverse Events (TRAEs) | Assessed from the first dose of neoadjuvant therapy to 90 days after the last study drug administration (with 30-day post-treatment safety follow-up) | Incidence and severity of Treatment-Related Adverse Events (TRAEs) are defined as all adverse medical events judged to be related to Sacituzumab Govitecan and/or Tagitanlimab during the entire study period, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. This endpoint evaluates the safety and tolerability of the combined neoadjuvant regimen in resectable HNSCC patients. |
| Secondary | Health-Related Quality of Life (HRQoL) Assessed by EORTC QLQ-C30 | Assessed at baseline (prior to the initiation of neoadjuvant therapy), post-neoadjuvant therapy (3-6 weeks after the completion of neoadjuvant treatment), and at 6 and 12 months following surgical resection. | Health-related quality of life (HRQoL) was assessed via the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which measures physical, emotional, social and cognitive function, as well as cancer-related symptom burden in malignant tumor patients. HRQoL scores at baseline and post-treatment were compared to quantify the combined neoadjuvant regimen's impact on patients' daily function and overall well-being. Scale Specifications: All EORTC QLQ-C30 subscales (functional/symptom) and the global health status/QoL scale are scored 0-100. Higher scores reflect better functional status/global health, while higher scores on symptom scales indicate more severe symptom burden. |
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.
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/NCT07492914
GET https://conductscience.org/api/trials/v1/NCT07492914/registered