A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Recruiting
Phase 3
Interventional Study
Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
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About This Trial
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.
Trial Locations
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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 k…
Contacts