BridgeMD
Tests treatment safety and results for Gastric Junction Adenocarcinoma
Official title Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT06826079
What this study is testing
What is Sorbitol?
Sorbitol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastric 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
- The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 70
You may be able to join if
- Age: 18 years ≤ age ≤ 70 years, gender not restricted.
- Written informed consent obtained from the patient.
- Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and...
- ECOG PS score of 0-1.
- Normal major organ function, meeting the following criteria:
You likely can't join if
- Presence of distant organ metastasis and peritoneal disseminated metastasis.
- Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease]...
- Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous...
- Patients preparing for or having previously undergone organ or bone marrow transplantation.
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV/HCV, pneumonia, etc.), symptomatic...
- Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose \> 10mg/day prednisone or...
See the full eligibility criteria
- Age: 18 years ≤ age ≤ 70 years, gender not restricted.
- Written informed consent obtained from the patient.
- Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type...
- ECOG PS score of 0-1.
- Normal major organ function, meeting the following criteria:
- Blood routine examination criteria (no blood or blood product transfusion within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):
- HB ≥ 90 g/L;
- ANC ≥ 1.5×109/L;
- PLT ≥ 125×109/L;
- Biochemical examination criteria:
- TBIL \< 1.5ULN;
- ALT and AST \ 50ml/min (Cockcroft-Gault formula);
- Fertile women must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive...
- Presence of distant organ metastasis and peritoneal disseminated metastasis.
- Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis [excluding diverticular disease], systemic lupus...
- Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in...
- Patients preparing for or having previously undergone organ or bone marrow transplantation.
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV/HCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina...
- Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose \> 10mg/day prednisone or other equivalent how well it works hormones), and still using them within...
- Patients who have previously received platinum-based, fluorouracil-based chemotherapy or targeted therapy, patients whose target lesions have undergone radiotherapy during combination therapy, or patients who have...
- Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
- Have experienced significant clinically significant bleeding symptoms or have a clear bleeding tendency within the last three months, such as a history of black stool or hematemesis, or are at high risk of bleeding due...
- Have hypertension that cannot be well controlled with a single antihypertensive drug (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); have a history of unstable angina pectoris; have been...
- Urinalysis indicates proteinuria ≥ ++ and confirmed 24-hour urine protein quantification \> 1.0 g;
- Have long-term non-healing wounds or incompletely healed fractures;
- Have abnormal coagulation function and a bleeding tendency (INR must be within the normal range without anticoagulants 14 days before enrollment); patients treated with anticoagulants or vitamin K antagonists such as...
- Have experienced arterial or venous thrombotic events within the last year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by previous...
- Have a history of abuse of psychotropic drugs and are unable to quit or have mental disorders;
- Have serious concomitant diseases that, in the judgment of the investigator, pose a significant risk to the patient's safety or affect the patient's ability to complete the study;
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.