Peritoneal Cancer

Researchers are conducting a multi-center, open-label, single-arm Phase 12 study to evaluate the safety, radiation dosimetry, and early diagnostic performance of 18FFPyQCP in detecting several types of cancers including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study aims to assess how well this imaging agent works in these selected oncology conditions and understand its radiation exposure to patients. Participants receive a single dose of 18FFPyQCP followed by positron emission tomography PETcomputed tomography CT imaging during the PETCT imaging visit. The study includes two cohorts focusing on radiation dosimetry and diagnostic accuracy. Cohort A participants undergo radiation dosimetry assessment up to 360 minutes after injection, while Cohort B participants are evaluated for diagnostic performance in the peritoneum with follow-up procedures lasting up to 42 days. During the study, participants undergo PETCT scans and are monitored for adverse events from screening until 48 hours after injection. Women of childbearing potential must have negative pregnancy tests before imaging and use contraception during the study. Researchers will measure radiation dose, imaging accuracy, and safety outcomes. The total participation time ranges from the screening visit through follow-up assessments, up to approximately 42 days post injection.

Researchers are evaluating the use of 68GaBED003, a diagnostic imaging agent, in detecting multiple types of cancer including colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast carcinoma, and epithelial ovarian cancer. This Phase 2, open-label, single-arm study aims to assess how well 68GaBED003 performs in identifying these cancers through imaging techniques. Each participant will receive an injection of 68GaBED003 followed by positron emission tomography PETcomputed tomography CT scans during the imaging visit. The study includes a screening period, the imaging procedure, and a brief safety follow-up. The main focus is on the diagnostic accuracy of 68GaBED003, including tumor uptake and optimal imaging timing and dosage. Participants will undergo screening to confirm eligibility, including performance status and pregnancy testing for women of childbearing potential. They will receive the imaging agent and have PETCT scans at the imaging visit. Safety and tolerability are monitored up to 48 hours after injection, with follow-up assessments up to 42 days. The study measures how well 68GaBED003 detects cancer in the peritoneum and other sites, with the entire participation lasting a few weeks around the imaging and follow-up visits.

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 12 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 MDNA11s effects alone and with pembrolizumab.

Researchers are evaluating a blended e-health intervention designed to reduce fear of progression FOP in women with advanced gynecologic or breast cancer. This trial focuses on whether a combination of remote group sessions and online activities can help women manage their fear of cancer worsening, which is a common and distressing concern. The study aims to assess the feasibility and acceptability of this approach alongside its effects on FOP and related psychological symptoms such as distress and anxiety. Participants are randomly assigned to one of two groups for a 6-week program. The Mindful Living Program group attends three 60-minute group sessions during weeks 1, 3, and 6 and completes online sessions in weeks 2, 4, and 5. They practice mindfulness and coping skills daily for 10-12 minutes, receive a check-in call around week 3 or 4, and have access to supportive online resources. The comparison group participates in the Navigating Cancer Program with a similar schedule of group and online sessions plus a check-in call but without the daily mindfulness practice or additional online tools. During the study, participants complete questionnaires measuring fear of progression, distress, anxiety, mindfulness, and other psychological outcomes at the start, after 6 weeks, and at 12 weeks follow-up. Researchers monitor attendance, engagement, and usability of the intervention over 6 weeks and conduct follow-up assessments at week 12. The total participation time includes the 6-week intervention period plus follow-up, with safety and usability being key measures.

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 106kg to 3 x 107kg 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.

Researchers are evaluating mass-based response testing MRT to guide personalized hyperthermic intraperitoneal chemotherapy HIPEC for patients with peritoneal metastases from high-grade appendiceal adenocarcinomas and colorectal cancer. This study aims to improve treatment selection for patients who have unresectable disease or extensive cancer spread within the abdomen. The study evaluates whether MRT can help choose effective chemotherapy drugs tailored to the individual patients tumor. Participants with unresectable peritoneal metastases will have tissue biopsies tested with MRT to identify optimal chemotherapy drugs. Those with unresectable disease will receive iterative HIPEC IHIPEC, which combines repeated cycles of heated chemotherapy delivered inside the abdomen with systemic chemotherapy. The IHIPEC cycles start about three weeks after laparoscopy and are repeated approximately three times with six weeks between each treatment. During the study, participants will be monitored for up to 12 months. Researchers will assess the feasibility of using MRT to select personalized HIPEC regimens, overall survival, treatment complications, quality of life, financial impacts, tumor response, and chemotherapy delivery success. Assessments include tissue biopsies, laparoscopy, laboratory tests, and questionnaires every three months. This detailed monitoring helps evaluate the treatment process and its effects over time.

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 treatments effects and appropriate dosing. The trial begins with a dose escalation phase to determine the maximum tolerated dose and recommended doses of SIM0388 given via peritoneal perfusion. After establishing the dose, a dose expansion phase will evaluate the treatments effectiveness in managing malignant ascites. Participants receive sequential cohorts of increasing doses or the recommended doses 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 puncturedrainage-free survival. The study involves regular evaluations including physical exams, imaging, laboratory tests, and monitoring of treatment effects to gather comprehensive data on SIM0388s impact.

Researchers are conducting an open-label, multicenter phase 1 study to evaluate SIM0505 in adults with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SIM0505 in participants who have progressed after or are ineligible for standard treatments. This trial includes multiple advanced cancers such as platinum-resistant ovarian cancer, renal cell carcinoma, uterine serous carcinoma, and non-small cell lung cancer among others. Participants receive SIM0505 in cycles lasting 21 days each. The study has different phases including dose escalation, where multiple dose levels are explored to find the maximum tolerated dose, followed by dose optimization phases that evaluate 2 to 3 dose levels to determine the recommended dose and assess preliminary antitumor activity across specific cancer types. The dosing and evaluation are conducted sequentially across various cohorts. Throughout the trial, participants undergo regular assessments including evaluation of dose-limiting toxicities at the end of the first cycle, ongoing monitoring for adverse events during the dose escalation phase, and measurement of objective response rates during dose optimization. Eligibility requires measurable lesions and adequate organ function among other criteria. The study may involve tumor tissue sampling for biomarker testing and requires participants to adhere to contraception guidelines if applicable. The total duration varies based on dose escalation and optimization phases, with safety and activity monitored over extended periods.

Researchers are investigating the use of paclitaxel delivered directly into the abdominal cavity intraperitoneally to treat patients with metastatic appendiceal adenocarcinoma, a type of cancer that has spread within the peritoneal cavity. This Phase III study aims to find the maximum tolerated dose and evaluate the drugs effect on tumor response, survival, and other biological markers in participants with this condition. Participants will be assigned to either Phase I or Phase II based on when they join the study. In Phase I, small groups receive increasing doses of intraperitoneal paclitaxel every 14 days to identify the highest dose without intolerable side effects. Phase II participants receive paclitaxel at the recommended dose found in Phase I. Additionally, some supportive drugs like dexamethasone, diphenhydramine, and famotidine are given orally. The study will also assess various biological and genetic factors related to the cancer. During the study, participants will be monitored for safety and side effects throughout treatment and for about one year. Researchers will evaluate tumor response using pathology and imaging, track progression-free and overall survival, and study changes in circulating tumor DNA and other markers. Participants organ function and symptoms will be assessed, with ongoing safety checks until study completion. The total participation time varies depending on individual treatment and follow-up.

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.