Trial · NCT06793761
A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC
NCT06793761, Phase 2, Not yet recruiting, Beijing Tongren Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC. Trials, record NCT06793761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06793761
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC
- NCT number
- NCT06793761
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 260 participants, estimated
- Lead sponsor
- Beijing Tongren Hospital
- Conditions
- Head and Neck Cancer
- Interventions
- Pembrolizumab, Cisplatin, Nab-paclitaxel
- First posted
- 2025-01-27
- Last updated
- 2025-01-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-year progression-free survival rate (2y-PFS rate) | 2 year | To evaluate the 2y-PFS rate of neoadjuvant PD-1 inhibitors combined with chemotherapy in Arm 1 and Arm 3; PFS was defined as the time from patient enrollment to the occurrence of the following events (local progression/recurrence or distant metastasis (including neoadjuvant stage) assessed by imaging or biopsy, death from any cause) |
| Secondary | Pathological complete response rate (pCR rate) | 3 months | To evaluate the pCR rate of neoadjuvant PD-1 inhibitors combined with chemotherapy in Arm 1 and Arm 3; pCR was defined as the absence of residual invasive squamous cell carcinoma cells in the resected primary tumor specimen and lymph nodes |
| Secondary | Objective response rate (ORR) | 6 months | To evaluate the ORR of neoadjuvant therapy with PD-1 inhibitors plus chemotherapy in Arm 1 and Arm 3; ORR is defined as The proportion of patients whose tumor volume shrinks to a pre-specified value and can be maintained for a certain period of time. It includes the proportion of patients with complete remission (CR) and partial remission (PR) to the total number of evaluable cases. |
| Secondary | 3-year overall survival rate (3y-OS rate) | 3 years | To evaluate the 3y-OS rate of neoadjuvant PD-1 inhibitors plus chemotherapy in Arm 1 and Arm 3 in the overall population; OS was defined as the time from randomization until death from any cause. |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TRAEs) of pembrolizumab combined with chemotherapy in neoadjuvant therapy | 3 years | TRAEs include 5 levels, base on Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings. |
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/NCT06793761
GET https://conductscience.org/api/trials/v1/NCT06793761/registered