Phase II Study of Intraperitoneal Paclitaxel and Systemic Therapy for Gastrointestinal Cancer with Peritoneal Spread (STOPGAP-B)

Inclusion Criteria

• For Cohort A: Must have confirmed gastric or gastroesophageal cancer with peritoneal spread and a history of stomach cancer surgery. Other metastases are allowed.
• For Cohort B: Must have confirmed colorectal or appendiceal cancer with peritoneal spread. Other metastases are allowed. Patients eligible for surgery without prior systemic therapy are excluded.
• For Cohort C: Must have digestive tract cancers with peritoneal spread not included in Cohorts A and B, such as small bowel or liver-related cancers.
• Must have cancer spread to the peritoneum confirmed by tests or surgery.
• Must be 18 years or older.
• Must have a performance status score of 2 or less, indicating ability to carry out daily activities.
• Must have a life expectancy of more than 3 months.
• Must have adequate organ and blood function as determined by specific medical tests.
• Must be able to understand and sign a consent form.

Exclusion Criteria

• Have any bowel obstruction, except for stomach outlet obstruction due to cancer.
• Have uncontrolled illnesses, such as ongoing infections, heart failure, recent stroke or heart attack, or unstable heart conditions.
• Have had another cancer within the last 3 years, except for certain skin, prostate, or cervical cancers.
• Have had prior intraperitoneal therapy, except for a single exposure during surgery.
• Cannot comply with study procedures as judged by the doctor.
• Must not be pregnant or breastfeeding due to potential risks to the baby.
• Must agree to use effective birth control during and after the study.
• Have an active infection needing treatment.
• Have had surgery that prevents safe participation in the study.
• Have a history of active tuberculosis.
• Have any condition or treatment that could interfere with the study or is not in the participant's best interest.