New combo therapy aims to wipe out stomach cancer before surgery
NCT ID NCT07266025
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests two different drug combinations given before surgery for people with a specific type of stomach cancer (dMMR/MSI-H). Participants will receive the immunotherapy drug adebrelimab plus either chemotherapy or another immunotherapy drug (SHR-8068). The goal is to see if these combinations can completely eliminate the cancer before the patient undergoes surgery. The study plans to enroll 30 adults whose cancer is locally advanced but considered removable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adebrelimab (an immunotherapy drug) combined with either chemotherapy (XELOX) or another immunotherapy (SHR-8068)
- What this could lead to
- If successful, this could point toward a more effective pre-surgery treatment for a specific type of stomach cancer, potentially increasing the chance of eliminating all cancer before surgery.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 30 participants, so results may not apply broadly. The combination therapies may cause significant side effects, and it's unknown if they will improve long-term outcomes.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2030
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 years and older
- 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 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: * Male or female, age ≥ 18 years * Pathologically confirmed gastric or gastro-oesophageal-junction adenocarcinoma (Siewert II and III only) * dMMR confirmed by IHC or MSI-H confirmed by PCR * Investigator-assessed potentially curative resection feasible before study entry * CT or MRI clinical stage cT ≥ 2 N any M0 per AJCC 8th edition; laparoscopy with peritoneal washing cytology (and peritoneal biopsy if indicated) recommended to exclude peritoneal metastasis * ECOG performance status 0-2 * Able to swallow tablets * Expected survival ≥ 6 months * Laboratory values within 7 days before randomisation: ANC \> 1.5 × 10⁹/L, Hb ≥ 80 g/L, PLT ≥ 75 × 10⁹/L Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL/min/1.73 m² ALT and AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN (or TBIL \> 1.5 × ULN with direct bilirubin ≤ ULN); albumin ≥ 25 g/L INR or PT ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN (or on anticoagulation within therapeutic range) * Signed written informed consent; able to comply with protocol visits, treatment, labs, biospecimen collection * WOCBP must have negative serum pregnancy test within 72 h before randomisation, not breastfeeding, and use highly effective contraception from screening until 2 months after last adebrelimab/SHR-8068 or 6 months after last chemotherapy, whichever is longer * Men with pregnant partners or WOCBP partners must be surgically sterile or use highly effective contraception during study and for same post-treatment periods; no sperm donation allowed Exclusion Criteria: * Tumour histology squamous-cell, neuro-endocrine, or other non-adenocarcinoma types * Unresectable disease (tumour-related or surgical contraindication) or subject refuses surgery * Tumour requiring transthoracic surgical approach * CNS metastases and/or carcinomatous meningitis * Prior anti-gastric-cancer therapy (surgery, radiotherapy, chemotherapy, targeted, immunotherapy) except bypass for obstruction * Previous malignancy or concurrent malignancy except completely excised basal/squamous skin cancer, superficial bladder cancer, or in-situ prostate/cervix/breast cancer disease-free ≥ 5 years * Cardiac conditions: NYHA class \> II or LVEF \< 50 % on echo Unstable angina MI within 1 year Resting QTc \> 450 ms (M) or \> 470 ms (F) Clinically significant ECG abnormalities, complete LBBB, 3rd-degree AV block, 2nd-degree AV block, PR \> 250 ms Risk factors for QT prolongation (HF, hypokalaemia, congenital long-QT syndrome, family history of long QT or sudden death \< 40 y, concomitant QT-prolonging drugs) * History of GI perforation, intra-abdominal abscess, or bowel obstruction within 3 months or imaging/clinical signs of obstruction * Clinically significant bleeding or bleeding diathesis within 3 months (e.g. GI bleeding, haemorrhagic gastritis, vasculitis); positive faecal occult blood must be endoscopically cleared if still positive on repeat testing (unless gastroscopy within 3 months shows no lesion) * Arterial or venous thrombo-embolic event within 6 months (stroke, TIA, intracranial haemorrhage, cerebral infarction) * Hypersensitivity to any study-drug component * Severe hypersensitivity history to any monoclonal antibody * Pregnant or lactating women * Positive HIV antibody * Active hepatitis (HBsAg positive with HBV DNA ≥ 500 IU/mL; HCV antibody positive with HCV RNA \> ULN) * Prior therapy targeting CTLA-4/PD-1/PD-L1 or other T-cell co-stimulatory/immune-checkpoint pathways (including therapeutic vaccines) * Active autoimmune disease or autoimmune disease with relapse risk within 2 years (except stable hypothyroidism on replacement or well-controlled type 1 diabetes on insulin) * History of idiopathic pulmonary fibrosis, drug-related pneumonia, organising pneumonia (BOOP/COP), or CT evidence of active pneumonia at screening * Live attenuated vaccine within 4 weeks before first study dose or expected need during study * Immunodeficiency disorder or chronic systemic corticosteroids or other immunosuppressive therapy within 7 days before first dose (includes prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents) * Any condition that, in the investigator's opinion, increases study risk, interferes with protocol conduct, or compromises informed consent or compliance
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gastric adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One small incision vs several: robotic stomach cancer surgery put to the test
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a vaccine stop GI cancers from returning?
- Blood test aims to catch Cancer's return earlier