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New treatment option for Patients With Unresectable Locally Advanced or Metastatic Untreated...
Official title A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07118527
What this study is testing
What is SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection?
SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for patients with unresectable locally advanced or metastatic untreated gastric or gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged between 18 and 75 years (inclusive), male or female
- Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- ECOG performance status score of 0 to 1.
- Body weight ≥ 35 kg.
- Life expectancy ≥12 weeks.
You likely can't join if
- Current or previous meningeal metastases; presence of active brain metastases.
- Ascites, pleural effusion and pericardial effusion requiring treatment (such as puncture, drainage, etc.) within 2 weeks before randomization.
- people with other malignant tumors within 3 years before randomization.
- Have received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.
- With adverse reactions (ARs) from previous anti-tumor treatment that have not recovered to NCI-CTCAE v5.0 Grade ≤ 1.
- Use of other non-marketed clinical investigational products or interventions within 4 weeks before randomization.
See the full eligibility criteria
- Aged between 18 and 75 years (inclusive), male or female
- Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- ECOG performance status score of 0 to 1.
- Body weight ≥ 35 kg.
- Life expectancy ≥12 weeks.
- Must have at least one measurable lesion according to RECIST v1.1 criteria.
- Tumor tissue samples must be provided, and newly obtained tumor tissues are preferred.
- Adequate bone marrow and organ function；
- 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...
- 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...
- 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.
- Current or previous meningeal metastases; presence of active brain metastases.
- Ascites, pleural effusion and pericardial effusion requiring treatment (such as puncture, drainage, etc.) within 2 weeks before randomization.
- people with other malignant tumors within 3 years before randomization.
- Have received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.
- With adverse reactions (ARs) from previous anti-tumor treatment that have not recovered to NCI-CTCAE v5.0 Grade ≤ 1.
- Use of other non-marketed clinical investigational products or interventions within 4 weeks before randomization.
- Have undergone major surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before randomization.
- Patients with active autoimmune diseases or history of autoimmune diseases.
- Patients with known or suspected interstitial lung disease; patients with other severe lung diseases that seriously affect respiratory function within 3 months before randomization.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.