Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma

ConditionsGastric Cancer Second-line Treatment

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorFudan University

About this trial

This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand this study and voluntarily sign the informed consent form;

Between 18 and 80 years old (inclusive), male or female;

Patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology;

ECOG performance status 0-2;

Disqualifiers

Patients with other malignancies within 5 years before enrollment, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

Patients who have received allogeneic bone marrow transplantation or organ transplantation in the past;

Patients with severe cardiovascular diseases within 6 months before enrollment, including unstable angina or myocardial infarction;

Patients allergic to the study drug or any of its auxiliary preparations;

Trial population

250

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Albumin-bound Paclitaxel
Drug
This is a prospective observational study. We observe efficacy and survival of different treatment regimen.
Immune Checkpoint Inhibitor
Drug
Immune Checkpoint Inhibitor
Anti-angiogenic drug
Drug
Anti-angiogenic drug
Trastuzumab emtansine
Drug
Trastuzumab Emtansine

Treatment groups

250 Participants

are divided into 5 treatment groups

Group A: Group A (Albumin-bound Paclitaxel Monotherapy Group)1 intervention

Group B: Group B (Albumin-bound Paclitaxel and Anti-angiogenic Therapy Group)2 interventions

Group C: Group C (Albumin-bound Paclitaxel and Immune Checkpoint Inhibitor Group)2 interventions

Group D: Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group)3 interventions

Group E: Group E (Albumin-bound Paclitaxel and Trastuzumab Emtansine Group)2 interventions

Trial outcomes

Primary outcomes

objective response rate

The rate of complete response and partial response

Time frame

the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 12 months

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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