Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
Conditions
Brief summary
A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Detailed description
This study is a Phase II/III clinical trial, aimed to evaluate the efficacy and safety of Enlituo® combined with Anyouping® plus platinum and nab-paclitaxel chemotherapy as first-line therapy for advanced, recurrent or metastatic HNSCC. Phase II Part Approximately 60 participants will be enrolled and randomly assigned at a 1:1 ratio to the experimental group. Phase III Part Approximately 302 participants will be enrolled and randomly assigned in a 1:1 double-blind manner to the experimental group.
Interventions
DRUGEnlituo® + Anyouping® + PBC
Enlituo®：Enlituo® is administered according to the protocol. Anyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
DRUGPlacebo-Enlituo + Anyouping® + PBC
Comparator in Phase 2 is Anyouping® + PBC. Comparator in Phase 3 is Placebo-Enlituo + Anyouping® + PBC. Placebo-Enlituo (only in Phase 3)：Placebo-Enlituo is administered according to the protocol. Anyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
Sponsors
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol; * Aged ≥ 18 years; * Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy; * Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded. (Remark: Subjects previously treated with PD-1/PD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.) * Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment; * For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment.
Exclusion criteria
* Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin; * Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection; * Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment); * Participants eligible for curative-intent local therapy; * Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose); * Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements; * Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (Phase 3) | Up to 2 years. |
| Objective Response Rate (Phase 2) | Up to 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | Up to 2 years. | The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3. |
| Disease control rate | Up to 2 years. | The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3. |
| Progression-Free Survival | Up to 2 years. | The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3. |
| Objective Response Rate (Phase 3) | Up to 2 years. | The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively. |
| Overall Survival (Phase 2) | Up to 2 years. | — |
| Time to Progression | Up to 2 years. | The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 | From the date of informed consent signature until 28 days after the last dose (each cycle is 21 days, up to 35 cycles or 2 years). | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE V6.0. Incidence of AE leading to dose interruption, dose delay and treatment discontinuation. |
Countries
China
Contacts
CONTACTZheng Zhang
Outcome results
None listed