Peritoneal Cancer

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts: dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11's effects alone and with pembrolizumab.

Researchers are evaluating the safety and effectiveness of CHT102, a universal chimeric antigen receptor T-cell immunotherapy (U CAR-T), in treating patients with mesothelin-positive advanced solid tumors. This study focuses on patients with advanced or metastatic solid tumors that express mesothelin and have not responded to standard first-line therapies or have no recommended first-line treatment options. The trial is sponsored by Tianjin Medical University Cancer Institute and Hospital and aims to assess dose-related toxicities and treatment responses. The study includes a dose escalation phase where participants receive CHT102 allogeneic CAR T cells through multiple infusions. Treatment involves three transfusions of UCAR-T cells on days 1, 5, and 9 within a 28-day cycle. Different dose levels are tested, ranging from 2.5 x 10^6/kg to 3 x 10^7/kg of CAR-positive T cells per infusion, with dose increases between groups. This dose escalation helps determine the appropriate dosage for further evaluation. Participants will be closely monitored for safety, including the occurrence of dose-limiting toxicities up to 28 days after infusion. Researchers will also measure objective tumor response at 4 weeks and overall, as well as progression-free survival up to 6 months. The study involves regular assessments of organ function, tumor measurements by RECIST criteria, and evaluation of patient health status. Participants are expected to remain in the study for follow-up assessments as scheduled to evaluate treatment effects and safety.

This research aims to evaluate mass-based response testing (MRT) to select personalized hyperthermic intraperitoneal chemotherapy (HIPEC) treatments for patients with peritoneal metastases from high-grade appendiceal adenocarcinomas and colorectal cancer. It focuses on patients with unresectable disease where standard surgery is not possible. The study explores whether MRT can help tailor chemotherapy to improve treatment outcomes in this setting. Participants will undergo MRT on tissue biopsies to identify the best chemotherapy drugs for their cancer. Those with unresectable disease will receive iterative HIPEC (IHIPEC), which includes multiple HIPEC treatments combined with systemic chemotherapy, spaced about six weeks apart. The first IHIPEC begins three weeks after laparoscopy, and this treatment approach is personalized based on MRT results. During the study, participants will have diagnostic laparoscopies and biopsies, followed by up to three cycles of IHIPEC. Researchers will assess treatment feasibility, tumor response, survival, complications, quality of life, and financial impact over 12 months. They will also monitor tumor cell characteristics and chemotherapy effectiveness using MRT. Regular questionnaires and clinical evaluations will track participants' progress throughout the study period.

Researchers are evaluating intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for patients with malignant ascites, a common complication of malignant tumors. This phase I study aims to assess the safety, efficacy, and pharmacokinetic features of SIM0388 in this condition. The study includes both dose escalation and dose expansion parts to better understand the treatment's effects and appropriate dosing. The trial begins with a dose escalation phase to determine the maximum tolerated dose and recommended dose(s) of SIM0388 given via peritoneal perfusion. After establishing the dose, a dose expansion phase will evaluate the treatment's effectiveness in managing malignant ascites. Participants receive sequential cohorts of increasing doses or the recommended dose(s) of SIM0388 as monotherapy through abdominal perfusion. Participants will be monitored for safety, tolerability, and response to treatment over an average of two years. Assessments include observing dose-limiting toxicities, adverse events, objective response rate in ascites, time to progression in ascites, and puncture/drainage-free survival. The study involves regular evaluations including physical exams, imaging, laboratory tests, and monitoring of treatment effects to gather comprehensive data on SIM0388's impact.

Researchers are studying the use of paclitaxel delivered directly into the abdominal cavity (intraperitoneal) for people with metastatic appendiceal adenocarcinoma, a cancer that has spread within the abdomen and cannot be removed by surgery. This Phase I/II trial aims to find the safest and most effective dose of paclitaxel given every 14 days and to evaluate its effects on tumor response and patient outcomes. The study also explores various biological markers and tumor characteristics to better understand treatment response. Participants are assigned to either Phase I or Phase II based on when they join the study. In Phase I, small groups receive increasing doses of paclitaxel intraperitoneally to identify the maximum tolerated dose. Phase II participants receive the recommended dose found in Phase I. Additional medications like dexamethasone, diphenhydramine, and famotidine are given orally to support treatment. The study monitors tumor changes, survival, and biological markers over time. During the study, participants will be carefully monitored for safety and side effects for about one year. Researchers will assess tumor response using pathology and imaging, measure pharmacokinetics of the drug, and track clinical outcomes such as progression-free and overall survival. Participants will undergo regular evaluations and provide samples to study tumor behavior and treatment effects. The study continues until January 2028, allowing long-term observation of treatment impact and safety.

Researchers are evaluating technetium [99mTc]-H7ND injection, a radiolabeled fibroblast activation protein inhibitor, to diagnose peritoneal metastasis in patients with gastrointestinal malignant tumors. This phase II clinical study aims to assess both the safety and effectiveness of this injection, while also exploring the diagnostic threshold for detecting peritoneal metastasis in this patient group. Participants will receive technetium [99mTc]-H7ND injection during a surgical removal or exploratory procedure. The study monitors patients from 1 to 7 days after the injection to evaluate the diagnostic accuracy and safety of the agent. This is an open-access, self-controlled study conducted across multiple centers. During the study, patients will be closely observed for any adverse reactions and diagnostic outcomes. The primary outcome measure is the effectiveness of the injection in diagnosing peritoneal metastasis within 1 to 7 days following administration. Participants must comply with study requirements, including follow-up assessments and safety monitoring, until the study concludes in September 2025.

Researchers are evaluating treatments for advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary. The study focuses on patients with no visible tumor remaining after primary tumor debulking surgery. It aims to compare the time patients remain free from cancer recurrence when treated with different lengths of chemotherapy followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two groups. One group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib is taken orally daily, starting at a dose of either 200 mg or 300 mg. Treatment continues until disease progression, unacceptable side effects, or other stopping reasons. Tumor assessments using CT or MRI scans and blood tests for the tumor marker CA-125 are performed regularly to monitor disease status. During chemotherapy, clinical visits including blood tests and toxicity monitoring occur every 3 weeks, and pregnancy tests are done every 4 weeks for women of childbearing potential. During niraparib maintenance, visits and safety monitoring happen every 4 weeks for the first 11 months, then every 12 weeks afterward. Physical exams take place every 12 weeks. Safety is closely monitored through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in Europe, with follow-up lasting up to 8 years to assess recurrence-free survival and other outcomes.

Researchers are studying colorectal cancer patients with peritoneal metastasis who have undergone complete or near-complete tumor removal surgery (R0/R1 resection). The study aims to explore how the methylation status of circulating tumor DNA (ctDNA) in plasma after surgery can predict the length of time patients remain free from cancer recurrence. This observational study collects clinical data and uses advanced testing to better understand the relationship between ctDNA methylation and patient outcomes. Participants have their plasma tested for ctDNA methylation before surgery, one month after surgery, every three months up to 24 months, and whenever cancer recurrence is detected on imaging. The tests include ColonAiQ and GutSeer methylation techniques applied to blood plasma and tissue samples collected at specific time points. Patients are grouped based on their one-month postoperative plasma ctDNA methylation status as either positive or negative. During the study, participants follow regular hospital review protocols according to NCCN guidelines, including CT or MRI scans and blood CEA tests every three months. Blood samples for plasma separation and ctDNA testing are collected at scheduled intervals to monitor changes over time. The main outcome measured is the ability of ColonAiQ to predict recurrence-free survival, with secondary measures comparing GutSeer and dynamic ctDNA monitoring. The study follows patients for at least 24 months after surgery, with ongoing monitoring to assess disease progression and recurrence.

Researchers are evaluating the effects of an 8-week Healthy Eating Active Lifestyle (HEAL)-GYN program designed for patients with gynecologic cancer. This telemedicine-based rehabilitation focuses on lifestyle changes including exercise, nutrition, sleep, social integration, stress management, and avoiding risk behaviors like smoking and alcohol. The study aims to assess impacts on participants' confidence in managing their health, lifestyle habits, mental health, overall well-being, and biological markers. The HEAL-GYN program is led by a certified lifestyle medicine oncologist and involves personalized goal-setting and practical instruction on healthy living. Up to 64 participants will engage in this behavioral intervention conducted remotely. The program includes regular monitoring through surveys and wearable activity trackers to measure physical activity and sleep. Participants will complete surveys at the start, end of the 8-week program, and at 1-month and 3-month follow-ups. These surveys use validated tools to assess lifestyle factors, mental health, and quality of life. Home health visits will collect biometric data and blood samples to analyze lab values and biomarkers such as adiponectin, insulin sensitivity, and inflammatory markers. This comprehensive monitoring supports evaluation of the program’s effects over time.