Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed through a tissue biopsy with a specific type of stomach or gastroesophageal junction cancer (called adenocarcinoma, diffuse or mixed type) that doctors have assessed as surgically removable, at a certain stage of local growth, with no spread to distant parts of the body
• People who have already completed 3 to 6 cycles of a chemotherapy regimen called FLOT before surgery (including adjusted or reduced doses)
• People whose only prior cancer treatment has been FLOT chemotherapy — no other chemotherapy or targeted drug treatments beforehand
• People who have not had any surgery to partially or fully remove the tumour prior to the trial
• People aged 18 to 75 years old
• Women of childbearing potential who have had a negative pregnancy test within 7 days before joining the trial, and who agree to use highly effective contraception throughout the study
• Men who agree not to father a child during treatment and to use a condom during the treatment period; their female partners of childbearing potential must also agree to use adequate contraception
• People with a good general physical functioning level, assessed as ECOG score of 0 or 1 (confirm with trial site)
• People who have had scans (CT or MRI) confirming no cancer has spread to distant areas of the body, and no invasion of nearby organs
• People who have had a keyhole (laparoscopic) procedure at initial diagnosis — before starting FLOT — confirming no cancer spread across the lining of the abdomen (peritoneal carcinomatosis)
• People whose blood counts, liver function, and kidney function are considered adequate for surgery and a specialised heated chemotherapy procedure called HIPEC, as determined by the treating doctor
• People who are willing and able to give written consent and follow the study procedures

Who may not be able to join:

• People who did not receive any chemotherapy before surgery, or who received a chemotherapy regimen other than FLOT
• People with a known allergy or sensitivity to any of the drugs used in FLOT: 5-FU, leucovorin, oxaliplatin, or docetaxel
• People with other known medical reasons why they cannot receive 5-FU, leucovorin, oxaliplatin, or docetaxel
• People with significant active heart disease, such as coronary heart disease, cardiomyopathy, or heart failure classified as NYHA class III or IV (confirm with trial site)
• People with a clinically significant heart valve problem
• People who have had another cancer in the past that was not fully cured, or for which there has been no confirmed absence of disease for more than 3 years — with exceptions for certain treated skin cancers (basal cell carcinoma) and cervical carcinoma in situ
• People whose cancer has been found to be surgically unremovable — for example, because it has grown into major blood vessels or nearby organs (T4b), or because it has spread to certain lymph nodes considered distant spread
• People with another serious illness or active infection at the time of enrolment
• People who have had major surgery within 28 days before joining the trial
• People with liver cirrhosis rated as Child-Pugh B or worse, or any degree of cirrhosis combined with a history of liver-related brain complications (hepatic encephalopathy) or fluid build-up in the abdomen (ascites)
• People who are currently participating in, or have participated in, another interventional clinical trial within 30 days before joining this study
• People who are pregnant, breastfeeding, or planning to become pregnant
• People who are in a closed institution by order of an authority or court
• People receiving any other cancer treatment at the same time, including radiation therapy
• People with known significant scar tissue (adhesions) inside the abdomen from previous conditions or procedures
• People who already have cancer spread across the lining of the abdomen (peritoneal seeding) before the trial

Important: Always verify eligibility with the trial site directly before applying.