Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Camrelizumab

adriamycin 20mg/m2 d1-3 q3w maximum 6 cycles

Adriamycin

Jing Chen, MD, PhD

Jieying Zhang

To evaluate the efficacy and safety of the combination of adriamycin and Camrelizumab in the first-line treatment of advanced soft tissue sarcoma

Camrelizumab Plus Doxorubicin for the First Line Treatment of Adcanced Soft Tissue Sarcoma

Doxorubicin（A）Plus Camrelizumab(C) Versus Doxorubicin Alone for the First-line Treatment(T) of Select Type of Adcanced Soft Tissue Sarcoma(ACTS): a Randomised Controlled Multi Centers Trial

Wuhan Union Hospital, China

Director, Head of Sarcoma Department , Principal Investigator, Clinical Professor

Olaparib

Trabectedin

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

There are 2 cohorts. Both cohorts receive the same treatment:

* Cohort 1: Leiomyosarcoma and liposarcoma
* Cohort 2: Other bone or soft tissue sarcoma histologies

Treatment consists of 21-day cycles for a maximum of 18 months.

Trabectedin administered intravenously (IV) every 21 days

Rashmi Chugh, M.D.

This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals.

Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS will be estimated along with their 95% confidence intervals.

The frequency and rates of adverse events occurring in at least 5% of participants and rates of grade 3-5 adverse events will be tabulated by system organ class and preferred term using Common Terminology Criteria of Adverse Events (CTCAE), within each cohort.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Camrelizumab Plus Doxorubicin for the First Line Treatment of Adcanced Soft Tissue Sarcoma	NCT04910126	Soft Tissue Sar... Neoplasms, Conn... Sarcoma Metasta... Sarcoma,Soft Ti...	Camrelizumab Adriamycin	18 Years - 60 Years	Wuhan Union Hospital, China
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma	NCT04076579	Sarcoma Sarcoma Metasta...	Olaparib Trabectedin	16 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for sarcoma metastatic