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New treatment option for Locally Advanced Gastric or Gastroesophageal Junction Cancer
Official title Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer
ClinicalTrials.gov ID: NCT07522151
What this study is testing
What is Adebrelimab plus S-1 and oxaliplatin?
Adebrelimab plus S-1 and oxaliplatin is an investigational medicine, being studied as a potential treatment for locally advanced gastric or gastroesophageal junction cancer.
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 was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.
- Age: ≥18 years old, \<75 years old, both male and female are eligible.
- Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy +...
- Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.
- Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months...
You likely can't join if
- Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other...
- Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for...
- The subject's weight has decreased by more than 20% within 2 months before randomization.
- Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine...
- Known allergy to any component of the investigational drug (including adibelimab/placebo, tegafur, and oxaliplatin), or allergy to humanized...
- Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or...
See the full eligibility criteria
- Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.
- Age: ≥18 years old, \<75 years old, both male and female are eligible.
- Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes.
- Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.
- Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months before randomization can be provided.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1.
- Expected survival ≥ 6 months.
- Adequate organ and bone marrow function.
- Female people are either infertile or fertile, with a negative serum pregnancy test result within 3 days before the start of study medication and not in the lactation period. Fertile female people and male people whose...
- Consent has been obtained from the individual and the informed consent form has been signed, willing and able to comply with planned visits, study treatment, laboratory tests, and other trial procedures.
- Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types.
- Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer...
- The subject's weight has decreased by more than 20% within 2 months before randomization.
- Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization).
- Known allergy to any component of the investigational drug (including adibelimab/placebo, tegafur, and oxaliplatin), or allergy to humanized monoclonal antibody products.
- Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical...
- History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation (including allogeneic organ transplantation or allogeneic hematopoietic stem...
- Severe, unhealed or open wounds, active ulcers, or untreated fractures.
- Active severe digestive system diseases.
- Presence of interstitial pneumonia or interstitial lung disease.
- Severe cardiovascular or metabolic diseases.
- Active HBV or HCV infection (HBsAg positive and viral copy number ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the upper limit of normal at the research center), or co-infection with hepatitis B and hepatitis C.
- Active tuberculosis infection within 1 year before randomization (including but not limited to pulmonary tuberculosis, intestinal tuberculosis, etc.), or a history of active tuberculosis infection more than 1 year ago...
- Severe infection within 4 weeks before randomization.
- Known history of abuse of psychotropic drugs or drug addiction.
- Presence of other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participation in the study, or interfere with the study results, and patients considered unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.