NCT07118527 A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
| NCT ID | NCT07118527 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2025-08-18 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18 and 75 years (inclusive), male or female 2. Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. 3. ECOG performance status score of 0 to 1. 4. Body weight ≥ 35 kg. 5. Life expectancy ≥12 weeks. 6. Must have at least one measurable lesion according to RECIST v1.1 criteria. 7. Tumor tissue samples must be provided, and newly obtained tumor tissues are preferred. 8. Adequate bone marrow and organ function； 9. Women of childbearing potential must agree on abstinence (avoid heterosexual sex) or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of the investigational product(s). 10. Male patients whose partners are women of childbearing potential must agree on abstinence or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of investigational product(s). 11. Capable of giving informed consent, have signed and dated the informed consent approved by the Ethics Committee, and willing and able to comply with tests and other procedures at scheduled visits. Exclusion Criteria: 1. Current or previous meningeal metastases; presence of active brain metastases. 2. Ascites, pleural effusion and pericardial effusion requiring treatment (such as puncture, drainage, etc.) within 2 weeks before randomization. 3. Subjects with other malignant tumors within 3 years before randomization. 4. Have received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization. 5. With adverse reactions (ARs) from previous anti-tumor treatment that have not recovered to NCI-CTCAE v5.0 Grade ≤ 1. 6. Use of other non-marketed clinical investigational products or interventions within 4 weeks before randomization. 7. Have undergone major surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before randomization. 8. Patients with active autoimmune diseases or history of autoimmune diseases. 9. Patients with known or suspected interstitial lung disease; patients with other severe lung diseases that seriously affect respiratory function within 3 months before randomization. 10. History of active tuberculosis within 1 year before randomization, or history of active tuberculosis over 1 year without appropriate treatment. 11、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C. 12、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation. 13、Severe cardiovascular or cerebrovascular diseases. 14、Active bleeding (CTCAE Grade ≥ 2). 15、Gastrointestinal perforation, gastrointestinal fistula or abdominal infection within 3 months before randomization. 16、Uncontrollable tumor-related pain or symptomatic hypercalcemia. 17、Patients with Grade \> 1 peripheral neuropathy. 18、Vaccination of live attenuated vaccine within 28 days prior to randomization. 19、Previous use of anti-HER2 antibody-drug conjugates.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07118527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07118527 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT07118527 currently recruiting?
Yes, NCT07118527 is actively recruiting participants. Contact the research team at Shiwei.sun@hengrui.com for enrollment information.
Where is the NCT07118527 trial being conducted?
This trial is being conducted at Shenyang, China, Shanghai, China.
Who is sponsoring the NCT07118527 clinical trial?
NCT07118527 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 600 participants.