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New treatment option for Gastroesophageal Adenocarcinoma
Official title Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
ClinicalTrials.gov ID: NCT06985602
What this study is testing
What is Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery?
Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastroesophageal 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
- Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%.
- Phase 2: a mid-size study of how well it works
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 80
You may be able to join if
- Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
- Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT...
- From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable...
- Exclusion of peritoneal metastasis.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
You likely can't join if
- Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
- The primary lesion is considered unresectable from a medical or surgical technical perspective.
- Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered...
- Peripheral neuropathy of grade ≥2.
- Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
- Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
See the full eligibility criteria
- Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
- Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT scans, and multidisciplinary team (MDT) discussion.
- From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or...
- Exclusion of peritoneal metastasis.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit...
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Male or female. Age ≥ 18 years and ≤80 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
- Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
- The primary lesion is considered unresectable from a medical or surgical technical perspective.
- Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).
- Peripheral neuropathy of grade ≥2.
- Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
- Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
- Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Received any investigational drug within 4 weeks prior to the first dose of the study drug.
- Required systemic treatment with corticosteroids (daily \>10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.
- Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
- Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
- History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
- Presence of uncontrolled cardiac symptoms or conditions, such as:
- NYHA Class II or higher heart failure
- Unstable angina
- Myocardial infarction within the past year
- Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.
- History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.
- Active pulmonary tuberculosis infection diagnosed by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of untreated active tuberculosis infection more than one year ago.
- Active hepatitis B or hepatitis C.
- Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.
- Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Province, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Province, 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.