- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06081673
Penpulimab combinato con chemioterapia per la terapia neoadiuvante e adiuvante in pazienti con HNSCC resecabile
Uno studio clinico di fase II su penpulimab combinato con chemioterapia per la terapia neoadiuvante e adiuvante in pazienti con carcinoma a cellule squamose resecabile della testa e del collo
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Cina, 200011
- Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
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 :75mg/m2, D1, IV(21 days/cycle) albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Major pathological response(MPR)
Lasso di tempo: One year
|
Major pathologic response is based on the pathological examination on the post-operative specimens. |
One year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Disease-control Rate(DCR)
Lasso di tempo: Baseline up to 3 years.
|
The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks). |
Baseline up to 3 years.
|
|
Adverse event rate
Lasso di tempo: Baseline up to 3 years.
|
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). |
Baseline up to 3 years.
|
|
Disease-free survival at 2 years(DFS at 2 years)
Lasso di tempo: Baseline up to 2 years.
|
The proportion of subjects disease-free survival at 2 years |
Baseline up to 2 years.
|
|
Overall Response Rate (ORR)
Lasso di tempo: Baseline up to 3 years.
|
The proportion of subjects who achieves a best overall response of CR or PR. |
Baseline up to 3 years.
|
|
Local recurrence-free survival at 2years(LRFS at 2 years)
Lasso di tempo: Baseline up to 2 years.
|
The proportion of subjects local recurrence-free survival at 2years |
Baseline up to 2 years.
|
|
distant metastasis-free survival at 2 years(DMFS at 2 years)
Lasso di tempo: Baseline up to 2 years.
|
The proportion of subjects distant metastasis-free survival at 2years |
Baseline up to 2 years.
|
|
OS at 2 years
Lasso di tempo: Baseline up to 2 years.
|
The overall survival time refers to the time from initiating inductive therapy to death due to any cause. |
Baseline up to 2 years.
|
|
pathologic complete response(pCR)
Lasso di tempo: One year
|
Pathological examination showed the presence of 0% active tumor in the tissue specimen |
One year
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Neoplasie per tipo istologico
- Neoplasie della testa e del collo
- Neoplasie, ghiandolari ed epiteliali
- Carcinoma
- Carcinoma, cellule squamose
- Carcinoma a cellule squamose della testa e del collo
- Prodotti chimici inorganici
- Composti di cloro
- Composti di azoto
- Composti di platino
- Cisplatino
- penpulimab
Altri numeri di identificazione dello studio
- ALTER-HN001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .