Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Peritoneal Carcinomatosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care Chemotherapy — DRUG
  The most common regimens are FOLFOX, CAPOX, FLOT, CF, and CX. Other local institutional standard of care regimens as well as targeted agents for gastric/GEJ adenocarcinoma are allowed.
• Biospecimen Collection — PROCEDURE
  Plasma is to be submitted at baseline and every three months for the first year or until progression, whichever comes first. For patients who have progression, their last plasma sample should be at time of progression.
• Computed Tomography — PROCEDURE
  Restaging imaging with CT and/or diffusion weighted MRI with contrast will be obtained after completion of 12 weeks (+/- 2 weeks) of assigned treatment (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). At this point, patients with stable disease or a response will continue assigned treatment. In the absence of radiological or clinical progression, if clinically indicated by treatment team, patients may undergo diagnostic laparoscopy to assess surgical candidacy at which time a PCI assessment and biopsies of peritoneal nodules, peritoneal lavage could be performed. Cytoreduction can be offered to patients with a PCI \< 7 and if complete cytoreduction is feasible based on treating surgeon's discretion. If deemed a candidate for surgical cytoreduction, surgery should be performed within 6 weeks of the last study treatment in both arms.
• Diagnostic Laparoscopy — PROCEDURE
  After induction of general anesthesia, administration of preoperative antibiotics and placement of appropriate laparoscopic ports, peritoneal lavage will be performed by instillation of 200 ml of normal saline in the left upper quadrant and allowed to dwell for 5 minutes after which it will be aspirated for cytology. Extent of peritoneal disease burden will be ascertained as per the Peritoneal Cancer Index (PCI) scoring system as outlined in Appendix V.
• Intraperitoneal Port Placement — PROCEDURE
  Patients assigned to Arm B will undergo placement of indwelling tunneled intraperitoneal port with Teflon cuff following Step 1 randomization and during the diagnostic laparoscopy procedure.
• Magnetic Resonance Imaging — PROCEDURE
  Restaging imaging with CT and/or diffusion weighted MRI with contrast will be obtained after completion of 12 weeks (+/- 2 weeks) of assigned treatment (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). At this point, patients with stable disease or a response will continue assigned treatment. In the absence of radiological or clinical progression, if clinically indicated by treatment team, patients may undergo diagnostic laparoscopy to assess surgical candidacy at which time a PCI assessment and biopsies of peritoneal nodules, peritoneal lavage could be performed. Cytoreduction can be offered to patients with a PCI \< 7 and if complete cytoreduction is feasible based on treating surgeon's discretion. If deemed a candidate for surgical cytoreduction, surgery should be performed within 6 weeks of the last study treatment in both arms.
• Intraperitoneal Paclitaxel — DRUG
  Patients on Arm B will start systemic therapy + intraperitoneal paclitaxel as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization as per the schedule shown in the table below. Therapy will be administered on Days 1 and 8 of a 21-day cycle for 4 cycles.

Study Details

This study is being done to answer the following questions: Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer. If you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below. If you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen). If you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment. It is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in. Once you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon. There is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called "intra-abdominal adhesions". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help. After you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest/Abdomen/Pelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.

Key Dates

Start date

Aug 19, 2025

Status verified

Apr 2026

Primary completion

May 30, 2030

Completion

May 30, 2030

Study Design

Enrollment

148 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Step 1, Arm A (standard systemic therapy)
  Patients on Arm A will start systemic therapy with physician's choice of any standard-of-care systemic regimen for gastric/GEJ adenocarcinoma. Patients on Arm A will start systemic therapy as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization. After 12 weeks (+/- 2 weeks) of standard of care treatment, patients will undergo a restaging assessment as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned standard of care treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction.
• Experimental: Step 1, Arm B (Systemic Therapy + Intraperitoneal Paclitaxel)
  Patients on Arm B will start systemic therapy + intraperitoneal paclitaxel as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization. Therapy will be administered on Days 1 and 8 of a 21-day cycle for 4 cycles. After 12 weeks (+/- 2 weeks) of study treatment, patients will undergo restaging assessments as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned protocol treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction.

Primary Outcome Measure

Progression free survival (Phase II) [ Time Frame: From randomization to progression or death without documentation of progression, assessed up to 5 years. ]

Locations (55)

Find similar trials in Irvine, CA

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