The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC

NCT06895369 | Not Yet Recruiting Phase 2

• 1 other identifier: XiaohuaJiang
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). Study Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination. Endpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS). Hypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Pucotenlimab; Squamous Cell Carcinoma of Head and Neck; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Pathological complete response rate (pCR) after surgery

  The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.

Secondary Outcomes (1)

• Major pathological response rate

  The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.

Study Arms (1)

experimental group

EXPERIMENTAL

Patients will receive 3 cycles of Pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination.

Drug: Pucotenlimab

Interventions

Pucotenlimab DRUG

patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment

Also known as: Cisplatin, Docetaxel

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70 years old.
• Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).
• Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
• Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
• Performance Status: ECOG performance status of 0-1.
• Surgical Eligibility: Deemed eligible for elective standard surgery followed by standard adjuvant chemoradiotherapy/radiotherapy, as assessed by the investigator.
• Autoimmune Disease: No active autoimmune diseases.
• Concurrent Malignancy: No concurrent malignancies.
• Life Expectancy: ≥6 months.
• Biomarker Testing: Available tumor tissue samples for PD-L1 testing via Combined Positive Score (CPS) using 22C3 pharmDx assay (DAKO).
• Hematologic Parameters:
• ANC ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥100 g/L, WBC ≥3.5×10⁹/L.
• No transfusion within 7 days or bleeding tendency.
• Liver Function: ALT, AST, ALP, and total bilirubin ≤1.5× upper limit of normal (ULN).
• Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance \>60 mL/min.

You may not qualify if:

• Cachexia or multiple organ failure.
• Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
• Concurrent second primary malignancy (e.g., esophageal cancer).
• Severe active infection requiring systemic therapy.
• Uncontrolled comorbid medical conditions that may compromise protocol compliance, per investigator judgment, including:
• Severe cardiovascular/cerebrovascular diseases,
• Uncontrolled diabetes/hypertension,
• Active peptic ulcer,
• Uncontrolled infections.
• Dementia, altered mental status, or cognitive impairment affecting informed consent or questionnaire completion.
• Grade ≥2 peripheral neuropathy (per CTCAE v5.0).
• Grade ≥2 hearing impairment (per CTCAE v5.0).
• History of malignancy within the past 5 years (excluding cured non-melanoma skin cancer or carcinoma in situ).
• Known HIV-positive status or AIDS.
• Nasopharyngeal carcinoma or squamous cell carcinoma originating outside oral cavity, oropharynx, hypopharynx, or larynx (e.g., sinonasal tract, paranasal sinuses, or unknown primary).

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hanzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiaohua Jiang, Master

  Sir Run Run Hospital

  STUDY CHAIR

Central Study Contacts

Xiaohua Jiang, Master

CONTACT

13777469596; jxhua2008@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)