Soft Tissue Sarcoma

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

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 studying patients with soft tissue sarcoma of the extremity, trunk, or retroperitoneum to evaluate a shorter, five-day course of preoperative radiation therapy. This approach is being compared to the standard preoperative radiation given over 25 days to assess safety and effectiveness. The study is a Phase 2 trial sponsored by Stanford University focusing on treatment for this type of cancer. Participants will receive external beam radiotherapy delivering a total dose of 30 Gy divided into five equal daily fractions of 6 Gy each over 5 to 10 business days before surgery. This abbreviated radiation schedule aims to reduce the treatment duration while still targeting the tumor and any areas where microscopic disease might exist. During the study, participants will be monitored for post-operative complications up to 120 days after surgery. Researchers will also evaluate the rates of local cancer recurrence at 2 and 5 years following surgical removal. The study includes assessments of health status, and participants must attend scheduled visits for treatment and follow-up as part of their involvement, which continues until at least the primary outcome measurement is completed.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract GIT cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein FAP expression in tumor samples. This Phase 12a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PETCT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are evaluating the use of 68Ga-DOTATATE digital PETCT 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 PETCT 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 PETCT 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 the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

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 mgm2 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.