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

ConditionGastric Cancer or Gastroesophageal Junction Adenocarcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Oral Paclitaxel Solution Plus Fruquintinib

    Drug

    Patients received oral paclitaxel plus fruquintinib in 4-week cycles until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination.

  • Investigator Choice (IC) Chemotherapy

    Drug

    Investigator' choice of chemotherapy is given until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Oral Paclitaxel Solution Plus FruquintinibExperimental treatment 1 intervention
Group B: Investigator-Selected ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival（PFS）

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.

Time frame
assessed up to 1 year

Secondary outcomes

1

Objective response rate（ORR）

ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1

Time frame
assessed up to 1 year
2

Disease Control Rate（DCR）

DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1

Time frame
assessed up to 1 year
3

Overall survival（OS）

OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death.

Time frame
From randomization until death due to any cause, up to 3 years.
4

Adverse event

Use NCI-CTCAE version 5.0 for classification and grading.

Time frame
From first dose to 30 days post the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harbin Medical University

Lead sponsor

The Second Affiliated Hospital of Harbin Medical University

Sponsor institution

Source ClinicalTrials.gov
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