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Chemioterapia perioperatoria con radioterapia a basso dosaggio e Tislelizumab per l'adenocarcinoma gastrico o della giunzione gastroesofagea localmente avanzato

3 novembre 2026 aggiornato da: Gang Li, Jiangsu Cancer Institute & Hospital

Uno studio di fase II multicentrico randomizzato controllato di chemioterapia perioperatoria combinata con radioterapia a basso dosaggio e tislelizumab rispetto alla sola chemioterapia in pazienti con adenocarcinoma gastrico localmente avanzato o della giunzione gastroesofagea

This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

114

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210009
        • Reclutamento
        • Jiangsu Cancer Institute & Hospital
        • Contatto:
        • Investigatore principale:
          • Gang Li, PhD. MD.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II/III) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and/or non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.

Exclusion Criteria:

  1. History of surgery for gastric or gastroesophageal junction tumors;
  2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;

4.Poor nutritional status, defined as BMI <18.5 kg/m² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade >1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Chemioterapia

Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.

Sperimentale: Chemioterapia combinata con Tislelizumab

Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.Tislelizumab: 200 mg administered concurrently with chemotherapy on days 1 and 22 via intravenous infusion, for a total of 3 cycles. Low Dose Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pathological Complete Response (pCR) Rate (ITT Population)
Lasso di tempo: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

The pathological complete response (pCR) rate is defined as the proportion of patients in the intention-to-treat (ITT) population who achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pathological Complete Response (pCR) Rate (Surgical Population)
Lasso di tempo: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

The pathological complete response (pCR) rate in the surgical population is defined as the proportion of patients who undergo surgical resection and achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.
R0 Resection Rate
Lasso di tempo: At the time of surgery, based on pathological evaluation of the resected surgical specimen.

The R0 resection rate is defined as the proportion of patients who undergo surgical resection and achieve microscopically margin-negative resection (R0). R0 resection is defined as no residual tumor at the resection margins on histopathological examination of the surgical specimen, as assessed according to standard pathological criteria.

At the time of surgery, based on pathological evaluation of the resected surgical specimen.
Event-Free Survival (EFS)
Lasso di tempo: From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.

Event-free survival (EFS) is defined as the time from randomization (or from treatment initiation in single-arm studies) to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence after surgery, or death from any cause. Patients who do not experience any of these events at the time of analysis will be censored at the date of the last disease assessment.

From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.
Overall Survival (OS)
Lasso di tempo: From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.

Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last follow-up.

From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Gang Li, PhD. MD., Jiangsu Cancer Institute & Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 maggio 2026

Completamento primario (Stimato)

20 febbraio 2029

Completamento dello studio (Stimato)

20 febbraio 2031

Date di iscrizione allo studio

Primo inviato

6 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 febbraio 2026

Primo Inserito (Effettivo)

13 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • GAS-Jiangsu04

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 .