Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Capecitabine

Cisplatin

Floxuridine

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

1. Induction treatment:

   Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
3. Randomization
4. Surgery.
5. Postoperative IP treatment:

   Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once
6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral

Same as Arm A except no postoperative IP treatment.

Surgery

Franco Muggia, MD

This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.

A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal consolidation, was conducted in patients with locally advanced, potentially resectable gastric cancer or cancer of the gastro-esophageal junction (GEJ), both staged as T3N0, T4N0, any TN1 or TN2 disease. The data suggest that for patients with locally advanced gastric or GEJ cancer, systemic induction therapy, curative surgery with high Ro resection rates, and IP adjuvant therapy, has acceptable toxicity and encouraging survival outcome. The Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial has also shown that perioperative chemotherapy - chemotherapy given both before and after surgery - can provide a significant survival benefit.

The investigators hypothesize that adjuvant intraperitoneal salvage of cancer micrometastatic residues after surgery contributes to disease-free survival. The goal of this trial is to determine whether IP Floxuridine, added to adjuvant postoperative chemotherapy, prolongs patient's survival. This will be tested during the randomized open-label trial.

Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

A Randomized Phase-II Study of Patients With Locally Advanced Gastric of Gastro-Esophageal Adenocarcinoma Treated With Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine, Followed by Prolonged Administration of Capecitabine

This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.

Secondary outcome measure was not analyzed as study was terminated

NYU Langone Health

A-with IP Floxuridine

B-Without IP Floxuridine

This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.

Induction Treatment Only

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small numbers of subjects analyzed.

Number of Patients With One-year Recurrence-free Survival

Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients

Induction Treartment Only

Overall Study

Symptoms and General Pathology

Recurrence

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Interleukin-12

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Cohorts of 3-6 pts will be infused with escalating doses of modified T cells to establish the MTD of modified T cells. There are 5 planned dose levels: 3 x 10\^5, 1 x 10\^6, 3 x 10\^6, \& 1 x 10\^7 \& 3 x 10\^7 4H11-28z/fIL-12/EGFRt+ T cells/kg. Cohort I-IV \& VI will be treated escalating dose levels. Once the MTD of T cells is established, the next cohort will receive lymphodepleting cyclophosphamide dose of 750 mg/m\^2 or a regimen of cyclophosphamide dose 300 mg/m2 x 3 days concurrent with fludarabine dose 25-30 mg/m2 x 3 days 2-7 days prior to starting the T cell infusion at one dose level below the MTD. If MTD isn't established after Cohort IV, Cohort V will receive conditioning chemotherapy 2-7 days prior to starting the T cell infusion at the same dose as Cohort III. Pts in Cohort V received cyclophosphamide chemotherapy on Day 1 or cyclophosphamide concurrent with fludarabine on Day 1-3, followed 2 to 4 days later by T cell infusion. This cohort is closed to further accrual.

Production of Genetically-modified T cells

IP Catheter Insertion

Patients who do not have sufficient CAR T cells for the assigned dose cohort will be treated in the cohort for which cells are available.

Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells

Roisin O'Cearbhaill, MD

The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.

There are 2 phases to the study: the Screening Phase and the Intervention Phase. Only patients identified as eligible from the Screening Phase may enroll in the Intervention Phase.

Screening Phase: After signing Informed Consent 1 (Screening Informed Consent), the patient's MUC16ecto tumor expression will be determined as previously described. In order to be eligible for this protocol, the patient's ovarian, primary peritoneal or fallopian tube carcinoma must express the MUC16ecto protein detectable by IHC analysis of banked (paraffin embedded) or fresh biopsied tumor. After signing Informed Consent 1, approximately 2 weeks will elapse while the patient's banked tumor is tested for MUC16ecto expression. If a patient's tumor is found to express MUC16ecto, she will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC), which will be frozen for future use. The leukapheresis product will be stored until the end of the study in case future research tests related to this study are developed.

Intervention Phase: Patients must sign Informed Consent 2 (Intervention Informed Consent) before receiving treatment on the study before receiving treatment on the study.

Once the patient is eligible to receive the CAR+ T cells, the frozen leukapheresis product will be thawed and used to generate the 4H11-28z/fIL-12/EGFRt+ genetically-modified T cells. It is expected to take approximately 4-6 weeks to prepare the autologous CAR+ T cells.

On day 1-3 patients in cohorts V will receive conditioning chemotherapy with cyclophosphamide 750 mg/m\^2 or 300 mg/m2 cyclophosphamide concurrent with 25-30 mg/m2 fludarabine 2-7 days prior to the initial infusion of autologous CAR+T cells. Patients will receive autologous CAR+T cells in 2 infusions, the first IV and the second IP, each comprising about half the total dose. The IV infusion will be given first. The patient will then be closely monitored. One to 3 days later if clinically stable, the patient will receive the remaining dose of CAR+T cells IP. Patients in cohort I or -I will not receive cyclophosphamide, but will receive the T cells in the same manner (approximately half IV, followed by close monitoring and then 1-3 days later, if the patient is clinically stable, the remaining cells will be administered IP).

This is a standard phase I dose escalation trial.

Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

A Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

There are 5 planned dose levels of 4H11-28z/fIL-12/EGFRt+ T cells: 3 x 10\^5, 1 x 10\^6, 3 x 10\^6, and 1 x10\^7 and 3 x10\^7 4H11-28z/fIL-12/EGFRt+ T cells/kg. The first subject will be treated at dose level 1 (3 x 10\^5 4H11-28z/fIL-12/EGFRt+ T cells/kg). At least one week will elapse from the first patient's T cell infusions before the second patient is treated (on dose level 1) to allow for toxicity and safely assessment. 3 subjects will be enrolled in cohort I and followed for 30 days for safety assessments. If no DLT is observed after all three subjects have been observed for 30 days, a second cohort of 3 subjects will be enrolled at the same dose level (3 x 10\^54H11-28z/fIL-12/EGFRt+ T cells/kg) with the addition of cyclophosphamide plus or minus fludarabine.

which will be defined according to the RECIST criteria, version 1.1 and, in appropriate subjects, the immune-related Response Criteria (irRC) (80)

Stanford University

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Memorial Sloan Kettering Cancer Center

Neoplasm Metastasis

Neoplastic Processes

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Camrelizumab: 200 mg, intravenous infusion, d1, q3w;

Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;

S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;

Camrelizumab: 200 mg, intravenous infusion, d1, q3w;

Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;

S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;

The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment.

Camrelizumab; Nab-paclitaxel; S-1

Li Xiao, Phd

The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.

In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study

Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers	NCT00848783	Gastric Cancer Gastric Adenoca... Esophageal Canc...	Irinotecan Cisplatin Surgery Floxuridine Capecitabine	18 Years -	NYU Langone Health
Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers	NCT00848783	Gastric Cancer Gastric Adenoca... Esophageal Canc...	Irinotecan Cisplatin Surgery Floxuridine Capecitabine	18 Years -	NYU Langone Health
Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors	NCT02498912	Solid Tumors	Production of G... Cyclophosphamid... IP Catheter Ins... Infusion of 4H1... Fludarabine	18 Years -	Memorial Sloan Kettering Cancer Center
Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study	NCT05441254	Stage IV Gastri...	Camrelizumab; N...	18 Years - 75 Years	Zhongshan Hospital Xiamen University

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