Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.

Eligibility criteria

Qualifiers

Able to provide written informed consent prior to any study-specific procedures

Age ≥ 18 years

ECOG performance status 0 or 1

Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic

Disqualifiers

Known hypersensitivity to any component of the study drugs

Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)

Prior treatment with retlirafusp alf

Received any investigational drug within 4 weeks before first dose

Trial design

Treatments tested in this trial

  • Retlirafusp alfa + Apatinib + Nab-paclitaxel

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators