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| Name | Class |
|---|---|
| Biotech Pharmaceutical Co., Ltd. | OTHER |
| Lepu Biopharma Co., Ltd. | INDUSTRY |
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This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | This single-arm phase II study evaluates the efficacy and safety of docetaxel, nimotuzumab, and pucotenlimab combination therapy as second- or later-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy. All enrolled patients must have unresectable, radiotherapy-ineligible R/M HNSCC, and ≤2 prior lines of therapy. Following screening and informed consent, treatment endpoints are defined from first dose until disease progression, death, intolerable toxicity, consent withdrawal, new anti-tumor therapy initiation, or other protocol-specified discontinuation criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Combination Therapy | Drug | [Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, for 4-6 cycles (exact number determined by investigator assessment). Maintenance Regimen: [Nimotuzumab 400mg + Pucotenlimab 200mg], intravenous infusion, Day 1, every 3 weeks, until protocol-defined treatment endpoints are reached. Maintenance Therapy Eligibility: Subjects who meet both criteria after the last induction cycle: No disease progression confirmed by imaging and investigator assessment, and/or absence of intolerable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Imaging assessment after completion of the first 4-6 cycles of therapy (i.e.,at12-18weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| For CPS ≥20 and the Overall Population: Median Overall Survival (mOS) | 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. | At least up to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Yan Chen, Prof. | Contact | 020-87342926 | chenchuny@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| For CPS ≥20 and the Overall Population: Median Progression-Free Survival (mPFS) | 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. | At least up to 24 months. |
| PFS rates at 6 and 12 months | 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. | PFS rates at 6 months and 12 months will be recorded separately. |
| Duration of Response (DoR) | 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). | At least up to 24 months. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 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). | At least up to 24 months. |
| Quality of Life (QoL) | 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. | 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. |
| Psychological Scales Assessment as assessed by the Depression, Anxiety, and Stress Scale (DASS-21) | 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+. | 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. |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D000077143 | Docetaxel |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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