Oral Paclitaxel Plus Fruquintinib Verus Investigator's Choice in Second-Line Advanced Gastric Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarbin Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Oral Paclitaxel Solution Plus Fruquintinib
  • Investigator Choice (IC) Chemotherapy

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Harbin Medical University

Lead sponsor

The Second Affiliated Hospital of Harbin Medical University

Sponsor institution