NCT07552402
Not yet recruiting
Not Applicable
Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
Harbin Medical University1 site in 1 country150 target enrollmentStarted: May 30, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Harbin Medical University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Progression-free survival（PFS）
Overview
Brief Summary
The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 to 75 years, regardless of sex;
- •Histologically and/or cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.
- •Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);
- •Body weight ≥40 kg or BMI \>18.5 kg/m²;
- •No severe hematologic, hepatic, or renal abnormalities:
- •Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥90 g/L;
- •Chemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN in the absence of liver metastases, or ≤5×ULN if liver metastases are present; Serum creatinine (Cr) ≤1.5×ULN;
- •Urinalysis: Urine protein ≤1+; If urine protein is ≥2+, a 24-hour urine protein test must be performed, and enrollment is permitted only if the 24-hour urine protein is \<1.0 g;
- •ECOG Performance Status (PS) 0-1;
- •Life expectancy ≥12 weeks;
Exclusion Criteria
- •Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);
- •History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;
- •Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;
- •Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;
- •Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;
- •Active gastrointestinal conditions such as gastric/duodenal ulcer, ulcerative colitis, or bowel obstruction, or any other condition deemed by the investigator to carry a risk of gastrointestinal hemorrhage or perforation; history of gastrointestinal perforation or fistula within the past 6 months; or incomplete recovery from surgery related to gastrointestinal perforation or fistula;
- •Evidence of significant bleeding or history of bleeding (e.g., hematemesis, hemoptysis) within 2 months prior to randomization. Patients with melena and positive fecal occult blood test must undergo gastroenteroscopy to rule out active bleeding or active ulcer before enrollment;
- •Requirement for long-term use of proton pump inhibitors (PPIs) or H2-receptor antagonists during the trial; or use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first study drug dose;
- •Known active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis;
- •Active infections or serious infectious diseases, including but not limited to: HIV infection (positive HIV antibody), active hepatitis (active HCV infection defined as positive HCV RNA; HCV antibody-positive but RNA-negative patients are allowed), active HBV infection (HBsAg-positive with HBV DNA \>2000 IU/mL), bacteremia, severe pneumonia requiring systemic therapy, or active tuberculosis;
Arms & Interventions
Oral Paclitaxel Solution Plus Fruquintinib
Experimental
Oral paclitaxel solution: 200mg/m2, p.o., bid, on days 1, 8, and 15 of each 28-day cycle.
Fruquintinib: 4 mg orally once daily, 3 weeks on/1week off
Intervention: Oral Paclitaxel Solution Plus Fruquintinib (Drug)
Investigator-Selected Chemotherapy
Active Comparator
Investigator-selected chemotherapy includes injectable taxanes (paclitaxel injection, albumin-bound paclitaxel, docetaxel, etc.), irinotecan, etc., excluding oral paclitaxel solution. Regimens and doses shall be determined by the investigator in accordance with recommendations from current clinical guidelines.
Intervention: Investigator Choice (IC) Chemotherapy (Drug)
Outcomes
Primary Outcomes
Progression-free survival（PFS）
Time Frame: assessed up to 1 year
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Secondary Outcomes
- Objective response rate（ORR）(assessed up to 1 year)
- Disease Control Rate（DCR）(assessed up to 1 year)
- Overall survival（OS）(From randomization until death due to any cause, up to 3 years.)
- Adverse event(From first dose to 30 days post the last dose)
- Qualtiy of life assesd by EORTC QLQ-C30 v3.0(Evaluation from baseline to the 30 days post the last dose)
Investigators
Yanqiao Zhang
Professor
The Second Affiliated Hospital of Harbin Medical University
Study Sites (1)
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