Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
This is 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.
Interventions
40mg/m2, D1-14 BID PO Q3W
DRUGSintilimab Placebo
200 mg, D1 IV Q3W
DRUGSintilimab
200mg D1 IV Q3W
DRUGIpilimumab N01
1mg/kg, D1 IV Q6W
130 mg/m2 D1 IV Q3W
DRUGIpilimumab N01 Placebo
1mg/kg, D1 IV Q6W
Sponsors
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Expected survival ≥ 6 months. 5. 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. 6. 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. 7. 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
1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization. 2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage. 3. 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. 4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction. 5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption. 6. Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention. 7. Active uncontrolled bleeding or known bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) | 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. |
| Event-Free Survival (EFS) | Up to approximately 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pathological Complete Response (pCR) rate | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) | 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. |
| Clinical Down-staging Rate | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) | Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy. |
| R0 resection rate | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) | The R0 resection rate is defined as the proportion of participants who underwent R0 resection. |
| Overall survival (OS) | Up to approximately 5 years | OS is defined as the time from randomization to death due to any cause. |
| numbers of subjects with adverse events | Up to approximately 5 years | 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 |
| numbers of subjects with serious adverse events | Up to approximately 5 years | 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 |
Countries
China
Contacts
CONTACTChunxian Hu
Outcome results
None listed