Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma

Phase 2

Not yet recruiting

• Conditions: Gastric Cancer; Gastro Esophageal Junction Cancer
• Interventions: Drug: Surufatinib; Drug: Sintilimab; Drug: Oxaliplatin; Drug: S1

• Registration Number: NCT06447636
• Lead Sponsor: Fudan University

Brief Summary

For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophag...

Detailed Description

The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing in China, and it is one of the most common malignant tumors in China. Surgery is the only possible way to cure gastric and gastroesophageal junction adenocarcinoma, however, over 70-80% of gastric/gastroesophageal junction adenocarcinoma patients in China are in advanced stag...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Study Start: 2024-08-01
• Primary Completion: 2025-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• signed informed consent
• patients age 18-75 years;
• Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;
• ECOG 0-1, no surgery contraindications;
• Expected survival ≥3 months;

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Exclusion Criteria

• signs of distant metastases
• Prior chemotherapy, radiotherapy, surgery for gastric cancer;
• Significant cardiovascular disease
• major surgical procedure within 4 weeks prior to initiation of study treatment
• current treatment with anti-viral therapy or HBV
• pregnancy or breastfeeding
• history of malignancy within 5 years prior to screening
• Present or history of any autoimmune disease or immune deficiency;
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
• There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.
• Poorly controlled hypertension or diabetes;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib，sintilimab and SOX chemotherapy	S1	Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.
Surufatinib，sintilimab and SOX chemotherapy	Surufatinib	Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.
Surufatinib，sintilimab and SOX chemotherapy	Oxaliplatin	Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.
Surufatinib，sintilimab and SOX chemotherapy	Sintilimab	Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.

Primary Outcome Measures

Name	Time	Method
Pathological complete response（pCR）rate	From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Overall survival (OS)	From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Disease free survival (DFS)	From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China