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

Gastric Cancer Clinical Trial

Official title:

Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447636
• Other study ID #: SOLIDS-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: August 2028

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: Fenglin Liu, MD
• Phone: 13918765733
• Email: 18916871096[@]189.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2028
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Gastro Esophageal Junction Cancer

Intervention

Drug:
• Surufatinib
Surufatinib: 250mg qd,d1-21, q3w
• Sintilimab
Sintilimab:200mg ivdrip, d1, q3w
• Oxaliplatin
130mg/m2,iv drip for 2h,d1, q3w
• S1
S1:40~60mg Bid,d1~14, q3w

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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