Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC

NCT ID: NCT06081673

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2026-10-30

Brief Summary

This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle.

Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab).

Non-MPR patients receive standard adjuvant therapy

Group Type: EXPERIMENTAL

Penpulimab injection

Intervention Type: DRUG

Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2)； 200mg,D1, IV(21 days/cycle).

cisplatin

Intervention Type: DRUG

Cisplatin :75mg/m2, D1, IV(21 days/cycle)

albumin-paclitaxel

Intervention Type: DRUG

albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)

Interventions

Penpulimab injection

Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2)； 200mg,D1, IV(21 days/cycle).

Intervention Type: DRUG

cisplatin

Cisplatin :75mg/m2, D1, IV(21 days/cycle)

Intervention Type: DRUG

albumin-paclitaxel

albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients voluntarily joined the study, signed the informed consent, and had good compliance;
• Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
• Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
• Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Exclusion Criteria

• Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
• Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
• A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
• Abnormal function of major organs
• Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Min Ruan, PhD

Role: CONTACT

doctorruanmin@situ.edu.cn

18019790370

Facility Contacts

Min Ruan, PhD

Role: primary

doctorruanmin@situ.edu.cn

18019790370

Other Identifiers

ALTER-HN001

Identifier Type: -

Identifier Source: org_study_id