Clinical trial NCT06081673: Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
Official title: A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Major pathological response（MPR）
timeFrame: One year
Secondary outcomes:
measure: Disease-control Rate（DCR）
timeFrame: Baseline up to 3 years.
measure: Adverse event rate
timeFrame: Baseline up to 3 years.
measure: Disease-free survival at 2 years(DFS at 2 years)
timeFrame: Baseline up to 2 years.
measure: Overall Response Rate (ORR)
timeFrame: Baseline up to 3 years.
measure: Local recurrence-free survival at 2years(LRFS at 2 years)
timeFrame: Baseline up to 2 years.
measure: distant metastasis-free survival at 2 years(DMFS at 2 years)
timeFrame: Baseline up to 2 years.
measure: OS at 2 years
timeFrame: Baseline up to 2 years.
measure: pathologic complete response(pCR)
timeFrame: One year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: