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

Henan Cancer Hospital

Status and phase

Active, not recruiting

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: fruquintinib + sintilimab + SOX

Study type

Interventional

Funder types

Other

Identifiers

NCT05177068

HMPL-013-FLAG-G103

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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:
1. Absolute Neutrophil Count (ANC) ≥1.5×109/L, White Blood Cell≥3.5×109/L;
2. Platelet Count of ≥100×109/L;
3. Hemoglobin≥90g/L;
4. Total Bilirubin (TBIL) ≤1.5 x ULN;
5. 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;
6. Serum Creatinine (SCr) ≤1.0×ULN;
7. 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
Not participating in other clinical trials 4 weeks before and during the treatment

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
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)
Women who are pregnant or lactating
Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g
Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using of the investigational product or may affect interpretation of study results
Patients considered unsuitable for inclusion in this study by the investigator.