Gastrointestinal Stromal Tumor (GIST)

Researchers are investigating the safety and effectiveness of 5 years of adjuvant imatinib treatment in patients with gastrointestinal stromal tumors (GIST) who have a high risk of recurrence. This includes patients with tumor rupture defined by Nishida classification or those with tumors 10cm or larger and a high mitotic index. The study builds on previous findings that showed benefits of shorter imatinib treatment durations and aims to improve long-term outcomes for high-risk patients. Participants will receive imatinib mesylate orally at a dose of 400 mg once daily for 5 years. This treatment extends the current standard 3-year adjuvant therapy by an additional 2 years. The study focuses on patients who have had complete surgical removal of their tumor and meet specific high-risk criteria. The trial is a phase 2, open-label study without randomization or placebo. Throughout the 5-year treatment period, participants will be monitored for progression-free survival as the primary outcome. Researchers will assess tumor status and overall health through regular visits and laboratory tests to evaluate safety and response. The study will also monitor organ function and patient performance status to ensure ongoing suitability for treatment. Participation may last up to 5 years, including follow-ups to observe long-term effects of the therapy.

Researchers are evaluating a shorter course of preoperative radiation therapy for patients with soft tissue sarcoma located in the extremity, trunk, or retroperitoneum. This study aims to examine the safety and effectiveness of delivering radiation over five days, compared to the standard treatment which is spread over 25 days. The trial is a Phase 2 study sponsored by Stanford University focused on improving treatment convenience while monitoring outcomes. Participants receive external beam radiotherapy with a total dose of 30 Gy divided into five daily treatments, each delivering 6 Gy. This abbreviated radiation schedule is given prior to surgery, following the standard care plan of preoperative radiation and surgical resection. The study does not include a comparison group and is not blinded. During the trial, participants are monitored for complications occurring up to 120 days after surgery to assess safety. Researchers also track the rate of local cancer recurrence at 2 and 5 years post-surgery. Patients will undergo regular assessments related to treatment response and side effects to evaluate outcomes. Participation duration includes radiation treatment, surgery, and long-term follow-up for cancer control.

Researchers are evaluating the use of 68Ga-DOTATATE digital PET/CT imaging in diagnosing soft tissue sarcomas. This study aims to assess the feasibility and potential clinical benefits of this imaging method, which may improve image quality compared to existing PET techniques. It also explores tumor uptake kinetics and the possibility of using imaging results to plan future peptide receptor radionuclide therapy for patients with specific tumor types. Participants receive an intravenous injection of gallium Ga 68-HA-DOTA-TATE and undergo digital PET/CT scanning for 60 minutes within two weeks after starting standard chemotherapy. About 24 hours later, they are given a fludeoxyglucose F-18 injection, followed by another 60-minute digital PET/CT scan. The study uses advanced PET detector technology to evaluate tumor characteristics and simulate imaging with lower doses or faster acquisition times. During the study, participants undergo imaging assessments to measure regions with increased tracer uptake. Researchers monitor safety by tracking adverse events up to seven days after imaging. The study involves standard chemotherapy alongside the imaging procedures. The total participation duration varies but includes the imaging sessions around chemotherapy and safety follow-up shortly after. This research is sponsored by Ohio State University Comprehensive Cancer Center.

Soft Tissue Sarcoma (STS) is a cancer that forms in soft tissues like muscles, tendons, fat, blood vessels, and nerves. These tumors often have a protein called PDGFRb1, which is targeted by treatments such as olaratumab. This trial is evaluating a new imaging agent, 89Zr-TLX300-CDx, which combines olaratumab with a radioactive metal, zirconium-89, to help detect STS and identify patients who might benefit from future PDGFRb1-targeted therapies. Participants will receive a single injection of 89Zr-TLX300-CDx and undergo whole-body imaging at various times depending on the study part. Part A and B include imaging at about 6 days after injection, with optional imaging at 4 hours. Part C involves imaging at 24 hours, 4 days, and 7 days post-injection, plus optional early dynamic imaging. Blood samples will be taken before injection and at multiple time points afterwards to study how the drug moves through the body. During the study, participants will have imaging scans and blood collections to assess safety, how the drug spreads and is processed, radiation exposure, and tumor targeting. The primary outcomes include safety and tolerability over 30 days, biodistribution and radiation dosimetry at 6 days, and pharmacokinetics. The study will help guide the future use of olaratumab as a radiopharmaceutical for STS. Participation involves visits for injections, imaging, and blood tests, with monitoring continuing for up to 30 days.

Researchers are studying a new type of scan called FAPI-PET/CT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

Researchers are studying the safety and effectiveness of a modified herpes simplex virus called R130 for treating advanced bone and soft tissue tumors, including osteosarcoma and sarcoma. This early-phase, open-label clinical trial aims to learn how this oncolytic virus works in patients who have relapsed or refractory tumors and have not responded to standard treatments or choose not to receive other therapies. Participants will receive injections of 1 to 2 ml of R130, containing 1x10^8 plaque-forming units per milliliter, directly into their tumors every 7 to 14 days. The treatment focuses on patients with measurable lesions suitable for direct injection. This single-arm study does not include a comparison group and is sponsored by Shanghai Yunying Medical Technology. During the study, patients will be closely monitored for adverse events and laboratory changes up to 6 months after treatment. Researchers will assess immune responses, disease control, duration of response, and quality of life over a 12-month period with scheduled evaluations every 6 to 10 weeks. Participants must meet certain health and organ function requirements and will be followed for safety and outcomes throughout the trial.

Researchers are evaluating the preliminary effectiveness of intratumoural tigilanol tiglate in patients with advanced or metastatic soft tissue sarcoma located in the extremities and body wall. This Phase IIa open-label study aims to assess tumour destruction following one or more treatments and the overall disease control beyond injected tumours. Additional goals include assessing safety, tolerability, systemic exposure, immune response, and progression-free survival in certain stages of the study. Participants will receive one or multiple injections of tigilanol tiglate directly into their tumours at a dose up to 3.6 mg/m2 based on body surface area. The treatment is administered intratumourally and may be guided by palpation or ultrasound. The study is open label with a single treatment arm, and the effects of the drug on injected and sometimes non-injected tumours will be monitored over time. Throughout the study, participants will undergo various assessments including tumour response evaluations at 3 and 6 months after initial treatment. Researchers will monitor adverse events for safety up to 6 months and perform pharmacokinetic testing after the first dose. Additional exploratory assessments include tumour microenvironment analysis, immune response, local recurrence rates, and metabolic profiling. Overall, participant involvement includes treatment, follow-up visits, safety monitoring, and outcome measurements lasting at least 6 months.

Researchers are investigating the safety of laparoscopic surgery to remove gastric gastrointestinal stromal tumors (GIST) that are 5 cm or larger. This prospective, multicenter cohort study aims to compare the clinical outcomes of laparoscopic resection of large gastric GISTs with those of smaller tumors less than 5 cm. The main focus is to evaluate overall postoperative complications within 30 days after surgery or upon discharge if the hospital stay is longer. The study involves two groups: patients undergoing laparoscopic removal of gastric GISTs 5 cm or larger, and those with tumors smaller than 5 cm receiving the same procedure. The laparoscopic approach is expected to achieve complete tumor removal (R0 resection). Various postoperative measures will be observed, including rates of complications during and after surgery, conversion to open surgery, surgical margin status, and changes in blood tests such as white blood cell count, hemoglobin, and C-reactive protein. Participants will be closely monitored after surgery through assessments of recovery milestones like time to first movement, bowel function, diet progression, and duration of hospital stay. Long-term outcomes including 3-year overall survival, disease-free survival, and recurrence patterns will also be recorded. The total follow-up spans up to 36 months, with detailed postoperative evaluations conducted up to 30 days and blood tests monitored before and after surgery at specified intervals.

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 a new T-cell membrane-anchored tumor targeted IL12 (attIL12)-T cell therapy combined with cyclophosphamide in patients with advanced or metastatic soft tissue or bone sarcomas. This phase 1 trial aims to find the best dose for treatment and to understand the safety, tolerability, and early signs of disease control, especially in patients with recurrent unresectable osteosarcoma. The study also explores immune responses and tumor cell changes related to the therapy. Participants will receive attIL12-T cell therapy combined with cyclophosphamide administered intravenously. The study includes two parts: Part A focuses on finding the safe and recommended dose, starting with the lowest dose, while Part B involves treating patients with osteosarcoma at the recommended dose found in Part A. Treatment schedules depend on the participant's group and study phase. During the trial, participants will undergo tumor biopsies when possible and provide blood samples to assess immune changes. Researchers will monitor adverse events to evaluate safety for about one year. The main measurement is the incidence of side effects, and disease control will also be assessed over four months. Participants must meet specific health and organ function criteria and will be closely followed up throughout the study period.