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
Locations
1Sponsors and collaborators
Henan Cancer Hospital
Lead sponsor