Trial · NCT07354984
A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT07354984, Phase 2, Not yet recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Trials, record NCT07354984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07354984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- NCT number
- NCT07354984
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Interventions
- Drug Combination Therapy
- First posted
- 2026-01-21
- Last updated
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Imaging assessment after completion of the first 4-6 cycles of therapy (i.e.,at12-18weeks) | |
| Secondary | For CPS ≥20 and the Overall Population: Median Overall Survival (mOS) | At least up to 24 months. | mOS is defined as the time from from Day 1 of treatment initiation until death from any cause. mOS corresponds to the time point at which the Kaplan-Meier curve of overall survival probability reaches 50%, estimated using non-parametric interpolation. This endpoint will be analyzed in months. |
| Secondary | For CPS ≥20 and the Overall Population: Median Progression-Free Survival (mPFS) | At least up to 24 months. | mPFS is defined as the time from Day 1 of treatment initiation until the first occurrence of disease progression (per RECIST v1.1), or death from any cause. mPFS corresponds to the time point at which the Kaplan-Meier curve of progression-free survival probability reaches 50%, estimated using non-parametric interpolation. This endpoint will be analyzed in months. |
| Secondary | PFS rates at 6 and 12 months | PFS rates at 6 months and 12 months will be recorded separately. | PFS is defined as the time from the day of first study drug administration to tumor progression (in any aspect) or death (from any cause). PFS rates at 6 months and 12 months will be recorded separately. |
| Secondary | Duration of Response (DoR) | At least up to 24 months. | Defined as the time interval from the first documented complete response (CR) or partial response (PR) per RECIST v1.1 criteria until disease progression or death (whichever occurs earlier). Units are days or months (e.g.,days or months). |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | At least up to 24 months. | Throughout this study and during the follow-up period, the severity of adverse events will be graded according to NCI-CTCAE v5.0. Safety evaluation metrics include: Incidence, severity, and relationship to the study drug of: All Adverse Events (AE) Treatment-Emergent Adverse Events (TEAE) Serious Adverse Events (SAE) Immune-Related Adverse Events (irAE). |
| Secondary | Quality of Life (QoL) | Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment. | The QoL was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), Version 3.0, which represent functions, symptoms, or health conditions. The EORTC QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life. |
| Secondary | Psychological Scales Assessment as assessed by the Depression, Anxiety, and Stress Scale (DASS-21) | Baseline, at the end of cycles 2 or 3 (each cycle is 21 days), at the end of cycles 4 or 6 (each cycle is 21 days), and within one week after the final treatment. | Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluationoflife, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non specific arousal. Recommended cut-off scores for conventional severity labels（normal,moderate,severe) are as follows: NB Scores on the DASS-21 will need to be multiplied by 2 to caculate the final score: Depresslon: normal:0-9, mild:10-13, moderate:14-20, severe: 21-27, extremely severe: 28+. Anxlety: normal:0-7, mild: 8-9, moderate:10-14, severe: 15-19, extremely severe: 20+. Stress: normal: 0-14, mild: 15-18, moderate:19-25, severe: 26-33, extremely severe:34+. |
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/NCT07354984
GET https://conductscience.org/api/trials/v1/NCT07354984/registered