Conversion Therapy of Fruquintinib in Combination With Sintilimab and SOX in Unresectable Gastric Cancer

NCT05177068 | Active Not Recruiting Phase 2

• 1 other identifier: HMPL-013-FLAG-G103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical complete resection rate (R0)

  This is a complete macroscopic resection of the gross tumor with negative surgical margins

  about 3 years

Secondary Outcomes (8)

• Rate of downstaging

  about 3 years

• Pathological complete response (pCR) rate

  about 3 years

• Major pathological response (MPR)

  about 3 years

• Objective Response Rate (ORR)

  about 3 years

• Event-free survival (EFS)

  about 3 years

Study Arms (1)

Experimental

EXPERIMENTAL

fruquintinib + sintilimab + SOX (S-1 + oxaliplatin)

Drug: fruquintinib + sintilimab + SOX

Interventions

fruquintinib + sintilimab + SOX DRUG

fruquintinib: 4mg/d, qd po, d1-14, q3w; sintilimab: 200 mg/d, IV d1, q3w; S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w; oxaliplatin: 130mg/m2, ivgtt 2-6h, d1, q3w

Experimental

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 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;
• Total Bilirubin (TBIL) ≤1.5 x ULN;
• ALT and AST\<2.5 x ULN, GPT≤1.5×ULN; If there is liver metastasis, then ALT and AST\<5.0 x ULN, GPT≤3.0×ULN;
• Serum Creatinine (SCr) ≤1.0×ULN;
• Endogenous creatinine clearance rate \> 60ml / min (Cockcroft Gault formula);
• No severe dysfunction of heart, lung and liver; No jaundice and gastrointestinal obstruction; No acute infection

You may not qualify if:

• Known HER-2 positive
• Distal metastasis to lung, brain, and bone
• Have received operation on the stomach
• 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
• Clinically significant electrolyte abnormalities judged by researchers
• With any diseases or conditions that affected drug absorption, or the patient could not take drugs orally
• Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months
• Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%
• Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）
• History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/m)

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: May 13, 2022
• Primary Completion: October 16, 2024
• Study Completion: December 31, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-02

Locations

CN (1)