Fruquintinib Combined With TAS102 for Advanced Gastric Cancer

NCT06102785 | Recruiting

• 1 other identifier: TJMUCH-GI-GC06
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib combined with TAS102 for second-line treatment of advanced gastric cancer.

Conditions

Gastric Cancer

Keywords

gastric cancer; second-line treatment; Fruquintinib; TAS102

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Time from the start of treatment to the progression of the disease

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcomes (3)

• Disease Control rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• The Overall Response Rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Overall survival

  From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months

Study Arms (1)

Fruquintinib combined with TAS102

Fruquintinib 4mg d1-21, q4w TAS102 35mg/m2，bid，d1-5，d15-19，q4w

Drug: Fruquintinib, TAS102

Interventions

Fruquintinib, TAS102 DRUG

Fruquintinib combined with TAS102

Fruquintinib combined with TAS102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced gastric cancer with second-line treatment

You may qualify if:

• Age ≥18 years old.
• The ECOG score is 0-1 and does not deteriorate within 7 days.
• Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
• Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
• Measurable lesions that meet RECIST 1.1 criteria.
• Have adequate organ and bone marrow function, laboratory tests meet the following requirements:
• HGB≥90g/L;
• NEUT≥1.5×10\^9/L;
• PLT ≥80×10\^9/L;
• TBIL≤1.5 times upper limit of normal value (ULN);
• ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;
• Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
• Urinary protein \< (++), or 24-hour urinary protein volume \< 1.0 g.
• Normal coagulation function, no active bleeding
• International standardized ratio INR≤1.5;

You may not qualify if:

• Previous treatment with VEGFR inhibitors;
• Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the disease progression);
• Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
• Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
• Previously received allogeneic bone marrow transplantation or organ transplantation;
• Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
• Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
• Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
• Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, stool, stool blood), hemoptysis, or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \> Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \< 50%;
• Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
• Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis \[Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \> 2000 IU/ mL); known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL);
• Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• 1. Zhang Y, Wang ZX, Shen L, et al. A phase Ib/II study of fruquintinib in combination withpaclitaxel as the second-line therapy for advanced gastric cancer. Cancer Commun (Lond) 2023; 43:150-153. 2. Shitara K, Doi T, Dvorkin M, et al. Trifluridine/tipiracil versus placebo in patients with heavilypretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3trial. Lancet Oncol 2018; 19: 1437-1448. 3. Gou M, Qian N, Zhang Y, et al. Fruquintinib in Combination With PD-1 Inhibitors in PatientsWith Refractory Non-MSI-H/pMMR Metastatic Colorectal Cancer: A Real-World Study in China. FrontOncol 2022; 12: 851756. 4. Takahara Y, Tanaka T, Ishige Y, et al. Efficacy and predictors of rechallenge with immunecheckpoint inhibitors in non-small cell lung cancer. Thorac Cancer 2022; 13: 624-630. 5. Nukatsuka M, Fujioka A, Nagase H, et al. Evaluation of a novel combination therapy, basedon trifluridine/tipiracil and fruquintinib, against colorectal cancer. Chemotherapy 2023.

  BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Ting Deng, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Deng, MD

CONTACT

022-23340123; xymcdengting@126.com

Jiayu Zhang, MD

CONTACT

15201752860; zhangjiayu152@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)