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

Starting soon · Phase 2

Conditions studied: Gastric Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT07610629

Run by

Henan Cancer Hospital

People needed

50

Starts

2026-05-05

Expected to finish

2029-06-30

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Human epidermal growth factor receptor 2 (HER2) negative
• Failed first-line immunotherapy-containing systemic treatment
• At least one measurable lesion per RECIST Version 1.1
• Adequate organ function:
• Hemoglobin ≥ 90 g/L 2)Absolute neutrophil count ≥ 1.5 × 10⁹/L 3)Platelet count ≥ 80 × 10⁹/L 4)Total bilirubin < 1.5 × upper limit of normal (ULN) 5)ALT/AST < 2.5 × ULN; < 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min 7)Urine protein < 2+ or 24-hour urine protein < 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment

You may not qualify if…

• 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
• Received systemic corticosteroid (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical/inhaled use or physiological replacement
• Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)
• Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation
• Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention
• Severe infection (CTCAE Grade > 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL) or active hepatitis C (HCV RNA positive)
• History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix
• Pregnant or lactating women
• Unwilling or unable to comply with study procedures
• Any other condition deemed inappropriate by the investigator

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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