Experimental drug combo aims to make inoperable stomach cancers removable

NCT ID NCT07709767

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether adding an experimental drug called retlirafusp alfa to standard chemotherapy can shrink advanced stomach or gastroesophageal junction cancers enough to allow complete surgical removal. Participants receive the drug combination before surgery, and those whose tumors respond well will undergo radical surgery. The main goal is to see how many patients achieve a clean surgical margin (R0 resection).

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 plus CAPOX chemotherapy (capecitabine and oxaliplatin)
What this could lead to
If successful, this approach could help more patients with advanced stomach cancer become eligible for surgery that completely removes the tumor.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply broadly. The combination therapy may cause significant side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by gastroscopic biopsy. 2. Potentially resectable gastric or gastroesophageal junction adenocarcinoma as judged by the investigator, including but not limited to: T4b disease or fixed/fused lymph nodes; single liver metastasis, limited para-aortic lymph node metastasis (No.16a2/b1), or CY1P0 disease; more than one liver metastasis or a liver metastasis larger than 5 cm adjacent to the hepatic vein or portal vein, extensive para-aortic lymph node metastasis (No.16a1/b2), or selected distant metastases such as Virchow lymph node or lung metastasis. 3. HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1. 4. Age 18 to 75 years. 5. Eastern Cooperative Oncology Group performance status of 0 or 1. 6. No prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 7. Adequate organ function, defined as: white blood cell count ≥3.0 × 10\^9/L; absolute neutrophil count ≥1.5 × 10\^9/L; platelet count ≥100 × 10\^9/L; total bilirubin ≤ upper limit of normal; AST and ALT ≤3 × upper limit of normal; serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL/min; activated partial thromboplastin time and international normalized ratio ≤1.5 × upper limit of normal; cardiac enzymes within normal range; and normal thyroid function. Participants with abnormal baseline TSH may be eligible if total T3 or free T3 and free T4 are within the normal range. 8. Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and agree to use effective contraception during the study and for at least 3 months after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for at least 3 months after the last dose. 9. Good compliance and willingness to complete study follow-up. Exclusion Criteria: 1. History of malignancy within 5 years or current presence of another malignancy. 2. Prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 3. Macroscopically visible peritoneal metastasis or other unresectable distant metastasis. 4. Active bleeding from the tumor as shown by endoscopy. 5. Use of traditional Chinese medicine with antitumor indication or systemic immunomodulatory drugs, including thymosin, interferon, or interleukin, within 2 weeks before the first dose, except for local use to control pleural effusion. 6. Requirement for systemic corticosteroids equivalent to prednisone \>10 mg/day or other immunosuppressive therapy within 14 days before the first dose or during the study, except for topical or inhaled corticosteroids or adrenal replacement therapy at a dose equivalent to prednisone ≤10 mg/day in the absence of active autoimmune disease. 7. Any active infection requiring systemic anti-infective therapy within 14 days before the first dose, except prophylactic antibiotics. 8. Thrombotic events within 6 months before screening, including cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism, except catheter-related venous thrombosis that has resolved as judged by the investigator. 9. Myocardial infarction or poorly controlled arrhythmia within 6 months before the first dose, including QTc interval ≥450 ms in males or ≥470 ms in females using Fridericia's formula. 10. New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<50% by echocardiography. 11. Known hypersensitivity to SHR-1701 or active ingredients or excipients of the chemotherapy drugs used in this study. 12. Known history of human immunodeficiency virus infection. 13. Untreated active hepatitis B, defined as HBsAg positivity with HBV DNA above the upper limit of normal at the study site. 14. Receipt of a live vaccine within 30 days before the first dose. 15. Active pulmonary tuberculosis. 16. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction. 17. Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis. 18. Poorly controlled diabetes mellitus, defined as fasting blood glucose \>10 mmol/L. 19. Any medical history, disease, treatment, laboratory abnormality, or other condition that may interfere with study results, prevent full participation in the study, or pose additional risk as judged 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.

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  1. The official record

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