A Phase II Clinical Study of Fruquintinib Combined With Sintilimab and SOX as Conversion Therapy of Potentially Resectable Stage IV Gastric Cancer

Henan Cancer Hospital1 site in 1 country42 target enrollmentMay 13, 2022

ConditionsGastric Cancer

Interventionsfruquintinib + sintilimab + SOX

Overview

Phase: Phase 2
Intervention: fruquintinib + sintilimab + SOX
Conditions: Gastric Cancer
Sponsor: Henan Cancer Hospital
Enrollment: 42
Locations: 1
Primary Endpoint: Surgical complete resection rate (R0)
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.

Detailed Description

Eligible patients will be given 3 or 6 cycles of combined therapy of fruquintinib + sintilimab + SOX. Then the patients evaluated resectable will be given one additional cycle of combined treatment with sintilimab + SOX, followed by R0 resection. If evaluated unresectable after 6 cycles of combination therapy, the patient will be given palliative first-line treatment. Adjuvant treatment with SOX regimen will be started 4 weeks after R0 resection for a total of 8 cycles in the perioperative period.

Registry

clinicaltrials.gov

Start Date

May 13, 2022

End Date

December 31, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed the Informed Consent Form
•Ages: 18-75 Years (concluding 18 and 75 Years)
•Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma, and meets one of the following conditions: invasion of adjacent organs such as colon, tail of pancreas and spleen; localized peritoneal metastasis; positive exfoliative cytology of ascites; class I, class II, part of class III and very few class IV stage IV gastric adenocarcinoma according to biological behavior; N3; extensive or fused lymph node metastasis; Krukenberg tumor; Liver metastasis limited to one lobe, less than 5cm in diameter, isolated abdominal aortic metastasis, etc;
•Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
•Life expectancy greater than 3 months
•ECOG(Eastern Cooperative Oncology Group) :0\~1
•Sufficient organ and bone marrow functions as follows:
•Absolute Neutrophil Count (ANC) ≥1.5×109/L, White Blood Cell≥3.5×109/L;
•Platelet Count of ≥100×109/L;
•Hemoglobin≥90g/L;

Exclusion Criteria

•Known HER-2 positive
•Distal metastasis to lung, brain, and bone
•Have received operation on the stomach
•A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer
•Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment
•Previously received allogeneic bone marrow transplantation or organ transplantation
•Known hypersensitivity to any of the study drugs or excipients
•Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg
•International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN
•Poorly controlled diabetes before enrollment