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

ConditionSquamous Cell Carcinoma of Head and Neck
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSir Run Run Shaw Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pucotenlimab

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response rate

Pathological complete response rate (pCR) after surgery

Time frame
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

major pathological response rate (MPR) of the treatment regimen

Time frame
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.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sir Run Run Shaw Hospital Status unavailable 310016, Hanzhou, ZhejiangChinaChina

Sponsors and contacts

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Sir Run Run Shaw Hospital

Lead sponsor

Source ClinicalTrials.gov

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