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Advanced Soft Tissue Sarcoma clinical trials

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NCT ID: NCT06062927 Recruiting - Clinical trials for Advanced Soft Tissue Sarcoma

Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma

Start date: February 2, 2023
Phase:
Study type: Observational

In this study, a new post-processing image technology - radiomics is used to screen out parameters of CT and MRI images, which could effectively evaluate the efficacy and prognosis of immunotherapy plus targeted therapy for soft tissue sarcoma (STS). A reliable and effective model for predicting the prognosis of STS will be established based on the radiomic parameters combined with traditional imaging, histophiological, whole exome sequencing (WES) results, inflammatory indicators and changes in the number and function of lymphocyte subsets before and after medication. Patients with advanced STS who may benefit from the combination therapy can be found out by this model.

NCT ID: NCT05876715 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

LINNOVATE
Start date: June 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.

NCT ID: NCT05809830 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas

Enhancer
Start date: May 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone

NCT ID: NCT05620693 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma

Start date: November 11, 2022
Phase: N/A
Study type: Interventional

Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no standard second-line treatment plan for patients who have failed first-line treatment. NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an ideal therapeutic target. Investigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced soft tissue sarcoma.

NCT ID: NCT05333458 Recruiting - Clinical trials for Advanced Soft Tissue Sarcoma

Testing Atezolizumab With or Without Selinexor in Patients >= 18 Years Old With Alveolar Soft Part Sarcoma, the Axiom Study

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether atezolizumab alone or in combination with selinexor works to shrink tumors in patients with alveolar soft part sarcoma and whether the study drugs are better than the usual approach in treating this type of cancer. The usual approach is defined as care most people get for alveolar soft part sarcoma if they are not part of a clinical study, which includes treatment with radiation, kinase inhibitor drugs, immunotherapy drugs, or chemotherapy drugs. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may help keep cancer cells from growing and may kill them. Giving atezolizumab alone or in combination with selinexor may help shrink tumors and stabilize the cancer in patients with alveolar soft part sarcoma.

NCT ID: NCT05182164 Recruiting - Osteosarcoma Clinical Trials

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

PEMBROCABOSARC
Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

NCT ID: NCT05180695 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

AMPHISARC
Start date: April 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is a two-step Phase I/II study comprising: Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib and escalating doses of HDM201. Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6M-PFR.

NCT ID: NCT05146440 Recruiting - Clinical trials for Advanced Solid Tumor

Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination With Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor

PRIME
Start date: November 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Phase Ib/II, multicohort, single arm, open-label, multicenter, international clinical trial, with 6 cohorts (advanced STS, advanced L-sarcomas, other advanced sarcomas, advanced solid tumors, and localized STS) with 4 sites in Spain for phase I. The aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity profile in advanced soft tissue sarcoma patients as monotherapy and also in other solid tumors as concomitant treatment with radiation therapy. Treatment Cohort A A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 24-h IV infusion on day 1 of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation. Cohort B A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 3-h IV infusion during 3 consecutive days (days 1-3) of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation. Cohort E PM14 will be administered at the recommended phase II dose (RP2D) according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity. Cohort F PM14 will be administered at the RP2D according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity. Cohort C Phase I: PM14 will be administered at the RP2D according to the most convenient scheme in 21-day cycles, at at different dose levels in combination with radiotherapy, up to progression or unacceptable toxicity. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation and during 2 additional days (in the 24-hour infusion) and during 3 additional days (in the 3-hour infusion). Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 3 Gy per fraction for 10 days (30 Gy in total). Phase II: PM14 will be administered at RP2D concomitant with radiation therapy. Cohort D Phase I: PM14 will be administered at the RP2D according to the most convenient scheme, in up to 3 x 21-day cycles in neoadjuvant setting, at different dose levels in combination with radiotherapy. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 1.8 Gy per fraction for 25 days (45 Gy in total). Phase II: PM14 will be administered at RP2D concomitant with radiation therapy.

NCT ID: NCT05099666 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

Lurbinectedin + Doxorubicin In Leiomyosarcoma

Start date: February 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This research study involves the study drug lurbinectedin in combination with doxorubicin. This research has two parts. The first part is being done to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a randomized study to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.

NCT ID: NCT05043649 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS

Start date: September 22, 2021
Phase: Phase 1
Study type: Interventional

This is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. The objective of the study is to evaluate the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of ASTS and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin with prophylactic pegfilgrastim. The primary endpoint is the MTD (RP2D).The secondary endpoints are: safety profile of camsirubicin with prophylactic pegfilgrastim, PFS, TTP, ORR, DoR, OS and PK. As exploratory endpoint, Quality of life will be measured by using the Functional Assessment of Cancer Therapy: General (FACT-G).