Trial · NCT07385079
Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma
NCT07385079, Phase 3, Not yet recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma. Trials, record NCT07385079. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07385079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma
- NCT number
- NCT07385079
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 412 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
- Interventions
- Anlotinib Hydrochloride Capsules, Gemcitabine (GEM), Cisplatin, Intensity-modulated radiotherapy, Benmelstobart
- First posted
- 2026-02-03
- Last updated
- 2026-02-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Failure-free survival (FFS) | 3 year | From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first |
| Secondary | Tumor response | the time of completion of induction chemotherapy, radiotherapy, and adjuvant immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 62 weeks | Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians |
| Secondary | Overall survival (OS) | 3 years | From date of randomization until the date of death from any cause, whichever came first |
| Secondary | Distant metastasis-free survival (DMFS) | 3 years | From date of randomization until the date of first documented distant metastasis, whichever occurred first. |
| Secondary | Locoregional recurrence-free survival (LRRFS) | 3 years | From date of randomization until the date of first documented locoregional recurrence, whichever occurred first. |
| Secondary | Adverse events (AEs) and serious adverse events (SAEs) | 3 years | Graded according to CTCAE V5.0. |
| Secondary | Quality of life (QoL) | week 1, 6, 24, 60, 72 | The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual. For the functional scales and the global health status scale, a higher score represents a better level of functioning or quality of life. For the symptom scales, a higher score indicates a greater severity of symptoms. |
| Secondary | Failure-free survival (FFS) within different subgroups | 3 years | analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. \>4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage. |
| Other | Correlation between pre-treatment PD-L1 expression level and FFS | 3 years | Pre-treatment PD-L1 expression level of tumor cell is evaluated centrally by means of immunohistochemical testing. |
| Other | Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level | 3 years | Subgroup analysis |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT07385079
GET https://conductscience.org/api/trials/v1/NCT07385079/registered