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

NCT ID: NCT06447636

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-08-31

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 gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.

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 stage. Locally gastric/gastroesophageal junction adenocarcinoma (cT3-4bNanyM0) could be cured by multi-disciplinary therapies including surgery, immunotherapy and chemotherapy. Perioperative immunotherapy plus chemotherapy can downstage tumor T and N stage, increase the R0 resection rate, and may improve the long-term survival. However, the therapeutic effects still not satisfactory to date. Surufatinib, as the novel oral antivascular targeting drug, has been proved to be effective in neuroendocrine tumor. Combination of perioperative surufatinib and immunotherapy plus chemotherapy for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.

Conditions

Gastric Cancer; Gastro Esophageal Junction Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib，sintilimab and SOX chemotherapy

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.

Group Type: EXPERIMENTAL

Surufatinib

Intervention Type: DRUG

Surufatinib: 250mg qd，d1-21, q3w

Sintilimab

Intervention Type: DRUG

Sintilimab：200mg ivdrip, d1, q3w

Oxaliplatin

Intervention Type: DRUG

130mg/m2，iv drip for 2h，d1, q3w

S1

Intervention Type: DRUG

S1：40\~60mg Bid，d1\~14, q3w

Interventions

Surufatinib

Surufatinib: 250mg qd，d1-21, q3w

Intervention Type: DRUG

Sintilimab

Sintilimab：200mg ivdrip, d1, q3w

Intervention Type: DRUG

Oxaliplatin

130mg/m2，iv drip for 2h，d1, q3w

Intervention Type: DRUG

S1

S1：40\~60mg Bid，d1\~14, q3w

Intervention Type: DRUG

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fenglin Liu

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

Central Contacts

Fenglin Liu, MD

Role: CONTACT

18916871096@189.cn

13918765733

Other Identifiers

SOLIDS-01

Identifier Type: -

Identifier Source: org_study_id