New triple therapy targets stomach cancer after immunotherapy fails
NCT ID NCT07610629
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of three drugs—retlirafusp alfa, apatinib, and nab-paclitaxel—in 50 adults with advanced stomach or gastroesophageal junction cancer that has progressed after first-line immunotherapy. The goal is to see if the combination can shrink tumors or slow disease progression. Participants receive treatment every three weeks for up to two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Retlirafusp alfa (a protein that targets PD-L1 and TGF-β), apatinib (a pill that blocks blood vessel growth), and nab-paclitaxel (a chemotherapy drug)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced gastric cancer whose disease has worsened after initial immunotherapy.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not be definitive. The combination may cause significant side effects, and it is not yet known if it will improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to provide written informed consent prior to any study-specific procedures 2. Age ≥ 18 years 3. ECOG performance status 0 or 1 4. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic 5. Human epidermal growth factor receptor 2 (HER2) negative 6. Failed first-line immunotherapy-containing systemic treatment 7. At least one measurable lesion per RECIST Version 1.1 8. Adequate organ function: 1)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 Exclusion Criteria: 1. Known hypersensitivity to any component of the study drugs 2. Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib) 3. Prior treatment with retlirafusp alf 4. Received any investigational drug within 4 weeks before first dose 5. 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 6. Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma) 7. Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation 8. Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention 9. Severe infection (CTCAE Grade \> 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis 10. Active hepatitis B (HBV DNA ≥ 2000 IU/mL) or active hepatitis C (HCV RNA positive) 11. 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 12. Pregnant or lactating women 13. Unwilling or unable to comply with study procedures 14. Any other condition deemed inappropriate by the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
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Other studies related to the condition(s) this trial covers.
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- Blood test aims to catch Cancer's return earlier