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Trial · NCT07457346

A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer

NCT07457346, Phase 2, Recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer. Trials, record NCT07457346. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07457346

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer
NCT number
NCT07457346
Status
Recruiting
Phases
Phase 2
Enrollment
76 participants, estimated
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
Head and Neck Cancer Squamous Cell Carcinoma
Interventions
cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib
First posted
2026-03-09
Last updated
2026-03-09

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPathological Complete Response (pCR) Rate in Cohort A (Resectable)approximately 12-14 weeks from the start of treatment
The proportion of participants in Cohort A (resectable locally advanced HNSCC) who achieve a pathological complete response (pCR) upon histopathological examination of the surgical resection specimen after 2 cycles of neoadjuvant therapy. pCR is defined as the absence of viable tumor cells (ypT0 ypN0) as per College of American Pathologists (CAP) criteria.
PrimaryObjective Response Rate (ORR) in Cohort B (Potentially Resectable)approximately 6 weeks from the start of treatment
The proportion of participants in Cohort B (potentially resectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
PrimaryObjective Response Rate (ORR) in Cohort C (Unresectable)approximately 6 weeks from the start of treatment
The proportion of participants in Cohort C (unresectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
SecondaryEvent-Free Survival (EFS)assessed up to 3 years.
EFS is defined as the time from enrollment to the occurrence of any of the following events: disease progression that precludes planned curative surgery (for Cohorts A/B), local or regional recurrence after definitive therapy (surgery or radiotherapy), distant metastasis, or death from any cause.
SecondaryOverall Survival (OS)assessed up to 3 years.OS is defined as the time from enrollment to death from any cause.
SecondaryIncidence of Treatment-Related Adverse Events (TRAEs)
From the first dose of study treatment until 90 days after the last dose. Continuous monitoring throughout the study, expected to be approximately 6 months for the neoadjuvant and definitive therapy phases, plus the 90-day safety follow-up.
The frequency and severity of all adverse events assessed as related to the study intervention (Adebrelimab, Sulfamethoxazole, cisplatin, and nab-paclitaxel). Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This includes the incidence of serious adverse events (SAEs), adverse events leading to treatment discontinuation or dose reduction, and specific events of interest such as immune-related adverse events (irAEs) and hematological toxicities.

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/NCT07457346

GET https://conductscience.org/api/trials/v1/NCT07457346/registered