Fruquintinib Combined with Sintilimab As Second-line Therapy for Gastric or Gastro-esophageal Junction Adenocarcinoma

NCT ID: NCT05625737

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2025-09-30

Brief Summary

This was a single-arm, prospective study to investigate the efficacy and safety of fruquintinib combined with sintilimab in the second-line treatment of Chinese patients with advanced gastric/GEJ adenocarcinoma.

Detailed Description

Patients with adenocarcinoma of the gastro-esophageal junction or the stomach who have documented progression after being treated with a 1st line chemotherapy can be included. All patients will receive a second line therapy with fruquintinib and sintilimab, a checkpoint inhibitor. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fruquintinib plus Sintilimab

Fruquintinib combined with sintilimab. Fruquintinib: 4 mg/d, qd, po, d1-14, q3w; Sintilimab: 200 mg/d, ivgtt, d1, q3w.

Group Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

Fruquintinib will be administrated as 4mg orally, once daily for 2 weeks on/1 week off.

Sintilimab

Intervention Type: DRUG

Sintilimab will be administrated as 200mg once every 3 weeks.

Interventions

Fruquintinib

Fruquintinib will be administrated as 4mg orally, once daily for 2 weeks on/1 week off.

Intervention Type: DRUG

Sintilimab

Sintilimab will be administrated as 200mg once every 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed the Informed Consent Form
• Ages: 18-75 Years (concluding 18 and 75 Years)
• Pathologically confirmed unresectable advanced gastric/gastroesophageal junction adenocarcinoma
• Failure to 1st line therapy, completed at least 28 days before enrollment
• HER2-negative
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than 3 months
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan, larger than 20 mm in diameter by conventional CT scan) according to RECIST1.1
• Sufficient organ functions as follows (any blood transfusion or cell growth factor use within 14 days before enrollment is not allowed):

Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet Count of ≥175×109/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL) ≤1.5 x ULN; ALT and /or AST<1.5 x ULN; If there is liver metastasis, then ALT and/or AST<3.0 x ULN; Serum Creatinine (SCr) ≤1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min；

• Man and woman who childbearing potential agrees to use adequate contraception
• Willingness to provide enough tumor tissues for PD-L1 expression test

Exclusion Criteria

• Patients could not obey the study protocol.
• Previous therapy with VEGFR Inhibitor.
• Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
• Known brain or CNS metastases.
• Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
• Uncontrolled malignant ascites.
• Clinically significant cardiovascular diseases, 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%.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Participation in another clinical trial with any experimental drug within 4 weeks prior to enrollment.
• Clinically significant electrolyte abnormalities judged by researchers.
• Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs.
• Poorly controlled diabetes before enrollment.
• Any factors that influence the usage of oral administration and patients cannot take fruquintinib orally.
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator.
• Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months.
• Active infection or serious infection that is uncontrolled by drug (NCI CTCAE v. 5.0 Grade ≥ 2).
• History of clinically significant hepatic disease, including hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml or >2000IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/ml).
• Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1).
• Pregnant or breastfeeding female patient.
• Receive blood transfusion, blood products and hematopoietic factors such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days prior to enrollment.
• Other severe acute or chronic medical conditions including metabolic disorder, physical examination or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
• Use of immunosuppressive medication, or systemic/local immunosuppressive corticosteroids for complication.
• Patients considered unsuitable for inclusion in this study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Hongli Liu

Director, Head of GI Department , Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongli Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Wuhan Union Hospital, China

Wuhan, Hubei, China

Countries

China

Other Identifiers

HMPL-013-CC-GC003

Identifier Type: -

Identifier Source: org_study_id