POF Versus FOLFOX Plus IP Paclitaxel in AGC

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus FOLFOX as first-line treatment in AGC with peritoneal metastases, a phase II Clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 18-75 years old;

• Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III

• Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.

• If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. PET/CT scan or MRI in addition to the CT scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.

• Patients must have ascites or peritoneal carcinomatosis confirmed by image (CT or MR or US or others) operation.

• Patients may have received no prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;

• An expected survival of ≥ 3 months;

• Major organ function has to meet the following criteria; (1) For results of blood routine test:

• Hemoglobin (HB) ≥ 80g / L,

• ANC(absolute neutrophil count) ≥ 1.5 × 109 / L,

• PLT(blood platelet) ≥ 75 × 109 / L, (2) For results of biochemical tests:

• BLT（total bilirubin） ≤ 1.25 times the upper limit of normal (ULN),

• ALT(Alanine aminotransferase) and AST(aspartate aminotransferase ) ≤ 2.5 × ·ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,

• Serum Cr（creatinine）≤1ULN, Endogenous creatinine clearance rate >50ml/min;

• The patient has a PT（prothrombintime） (INR international normalized ratio) < or = to 1.5 and an PTT（Partial Thromboplastin Time）< than or = to 3 seconds above the upper limits of normal if the patientia t is not on anticoagulation. ·If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:

• The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW(Low molecular weight) heparin

• The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)

• Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative.

• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

• Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.

Exclusion Criteria:

• Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible.

• Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.

• Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.

• Patients with brain or central nervous system metastases, including leptomeningeal disease.

• Pregnant (positive pregnancy test) or breast feeding.

• Serious, non-healing wound, ulcer, or bone fracture.

• Significant cardiac disease as defined as:

unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.

• History of a stroke or CVA within 6 months

• Clinically significant peripheral vascular disease.

• Inability to comply with study and/or follow-up procedures.

• Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.