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

NCT06447636 | Not Yet Recruiting Phase 2

• 1 other identifier: SOLIDS-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastro Esophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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

• 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

Study Arms (1)

Surufatinib，sintilimab and SOX chemotherapy

EXPERIMENTAL

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.

Drug: Surufatinib; Drug: Sintilimab; Drug: Oxaliplatin; Drug: S1

Interventions

Surufatinib DRUG

Surufatinib: 250mg qd，d1-21, q3w

Surufatinib，sintilimab and SOX chemotherapy

Sintilimab DRUG

Sintilimab：200mg ivdrip, d1, q3w

Surufatinib，sintilimab and SOX chemotherapy

Oxaliplatin DRUG

130mg/m2，iv drip for 2h，d1, q3w

Surufatinib，sintilimab and SOX chemotherapy

S1 DRUG

S1：40\~60mg Bid，d1\~14, q3w

Surufatinib，sintilimab and SOX chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

surufatinib; sintilimab; Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Fenglin Liu, MD

CONTACT

13918765733; 18916871096@189.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)