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Compares treatment options for Carcinoma
Official title XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT05494060
What this study is testing
What is Anlotinib hydrochloride capsule?
Anlotinib hydrochloride capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for carcinoma.
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 is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- people aged ≥18 and ≤75 years old, male or female.
- ECOG performance status score 0-1.
- Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.
- Pathological stage:III (8th AJCC TNM).
- Estimated lifetime is greater than 6 months.
You likely can't join if
- Participation in other drug clinical trials within four weeks.
- Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
- History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with...
- Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90...
- Long-term unhealed wound or unhealed fracture.
See the full eligibility criteria
- people aged ≥18 and ≤75 years old, male or female.
- ECOG performance status score 0-1.
- Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.
- Pathological stage:III (8th AJCC TNM).
- Estimated lifetime is greater than 6 months.
- The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:
- Routine blood test:
- Hemoglobin (HB) ≥90 g/L.
- Neutrophil count (ANC) ≥1.5×109/L.
- Platelet count (PLT) ≥100×109/L.
- Biochemical test:
- Total bilirubin≤1.5×ULN (upper limit of normal).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
- Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min.
- No obvious clinical symptoms of heart disease.
- Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT...
- Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of...
- Volunteer to participate in this study and sign an informed consent form.
- Considering that NGS analysis may take up to 10 working days, patients could receive 1 cycle of XELOX chemotherapy after ctDNA sampling.
- Participation in other drug clinical trials within four weeks.
- Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
- History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be...
- Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly...
- Long-term unhealed wound or unhealed fracture.
- Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive...
- Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically...
- Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous...
- Urine routine showed urine protein and 24 h urine protein was confirmed to be \> 1.0g.
- Previous use of immune targeted therapy drugs.
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids.
- History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic...
- Patients with hypersensitivity to human or murine monoclonal antibodies.
- Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders.
- Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention.
- Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the how well it works judgment or safety judgment.
- Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 Nanjing, Jiangsu, 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.