Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Chunxian Hu
- Telefonní číslo: +86 021 3183 7200
- E-mail: chunxian.hu@innoventbio.com
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510060
- Nábor
- Sun Yat-sen University Cancer Center
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Kontakt:
- Ruihua Xu
- Telefonní číslo: 020-87343468
- E-mail: xurh@sysucc.org.cn
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria
- Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 6 months.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
- Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
- Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.
Exclusion Criteria
- Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
- Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
- History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
- Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
- Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
- Active uncontrolled bleeding or known bleeding diathesis.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
200mg D1 IV Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
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Experimentální: Sintilimab+Ipilimumab N01
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
200mg D1 IV Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
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Aktivní komparátor: Sintilimab placebo+Ipilimumab N01 placebo
Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
40mg/m2, D1-14 BID PO Q3W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
200 mg, D1 IV Q3W
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Časové okno: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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Event-Free Survival (EFS)
Časové okno: Up to approximately 5 years
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The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
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Up to approximately 5 years
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Celkové přežití (OS)
Časové okno: Do cca 5 let
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OS je definován jako doba od randomizace do smrti z jakékoli příčiny.
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Do cca 5 let
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pathological Complete Response (pCR) rate
Časové okno: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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Clinical Down-staging Rate
Časové okno: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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R0 resection rate
Časové okno: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
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Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
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numbers of subjects with adverse events
Časové okno: Up to approximately 5 years
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defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
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Up to approximately 5 years
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numbers of subjects with serious adverse events
Časové okno: Up to approximately 5 years
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Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
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Up to approximately 5 years
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CIBI310M301
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