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Skin and Connective Tissue Diseases

Rare Diseases

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Sarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan Hydrochloride Liposome Injection is given weekly by 5 doses every 6 weeks (5/6 qw).

Irinotecan Hydrochloride Liposome Injection

Dongyuan Zhu, M.D.

Jin GU, M.D.

Jie Xu, M.D.

Xiaodong Tang, M.D.

Lu Xie, M.D.

The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.

After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades. The anti-tumor activity of irinotecan was demonstrated by several studies in the past. However, longer schedule of irinotecan infusion (traditionally dx5x2) has impacted quality of life in these patients. The irinotecan liposomes may be more active than the parent compound irinotecan since its ability to stay longer in circulation system, and much more convenient to given weekly.

Thus, the investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide. Bayesian Optimal Interval (BOIN) design is adopted in this dose-finding study.

Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma

To evaluate the maximum tolerated dose of weekly irinotecan liposomes for patients with relapsed or refractory Ewing sarcoma.

To assess the preliminary response rate of irinotecan liposomes in patients with relapsed or refractory Ewing sarcoma.

To assess the preliminary progression free survival of irinotecan liposomes in patients with relapsed or refractory Ewing sarcoma.

Peking University Shougang Hospital

Shandong Cancer Hospital and Institute

Peking University People's Hospital

M.D., Head of Musculoskeletal Tumor Center

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Topotecan

Patients will consecutively receive LY01610 on Day 1 q2wk (every two weeks = one treatment cycle)

Patients will consecutively receive Topotecan on Days 1-5 q3wk(every three weeks = one treatment cycle)

Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk

Irinotecan hydrochloride liposome Injection

Topotecan 1.2 mg/m² intravenously Days 1-5 q3w

yuankai shi, doctor

This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)

A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)

Overall survival is defined as the time from randomization to date of death.

Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first

Overall response rate (ORR) will be the best response obtained in any evaluation according to RECIST v.1.1

Overall survival rate at 1 year is defined as the percentage of people who are still alive at 12 months after randomization.

Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death

To measure the quality of life of patients, EORTC QLQ-C30/LC13 questionnaire will be analyzed

Maximum plasma concentration of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (Cmax) in 20\~24 subjects treated with LY01610

Time to maximum plasma concentration of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (Tmax) in 20\~24 subjects treated with LY01610

Area under the plasma concentration-time curve of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (AUC) in 20\~24 subjects treated with LY01610

Elimination half-life of total Irinotecan，free Irinotecan，and its metabolite SN-38，SN-38G (t1/2) in 20\~24 subjects treated with LY01610

Pharmacokinetic plasma concentration-time data for total Irinotecan，free Irinotecan，and its metabolite SN-38，SN-38G will be analyzed using population pharmacokinetic methods in all subjects treated with LY01610 and identify the effect of covariates on pharmacokinetic parameters in the subject population

Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug

Luye Pharma Group Ltd.

Neoplasms, Glandular and Epithelial

Capecitabine

Antimetabolites

Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle.

rinotecan hydrochloride liposome injection (70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

irinotecan hydrochloride liposome injection

Capecitabine (1000 mg/m\^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle

Yi Ba, PHD

Yi Ba

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.

Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma.

To identify the quality of life by QLQ-C30（V3.0）

CSPC Ouyi Pharmaceutical Co., Ltd.

Ba Yi

Director

LY01610(Irinotecan Hydrochloride Liposome Injection),Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study.

LY01610 will be administered via intravenous infusion every 2 weeks on Day 1

LY01610( Irinotecan hydrochloride liposome injection )

Yuankai Shi, Professor

This is a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that Progressed after first-line Antitumor Therapy.

The objectives are to evaluate the efficacy and safety of LY01610 in subjects with extensive small cell lung cancer that progressed after first-line antitumor therapy.

Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma	NCT06340204	Ewing Sarcoma	Irinotecan Hydr...	8 Years - 40 Years	Peking University People's Hospital
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma	NCT06340204	Ewing Sarcoma	Irinotecan Hydr...	8 Years - 40 Years	Peking University People's Hospital
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer	NCT06128837	Relapsed Small ...	Irinotecan hydr... Topotecan	18 Years -	Luye Pharma Group Ltd.
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer	NCT06128837	Relapsed Small ...	Irinotecan hydr... Topotecan	18 Years -	Luye Pharma Group Ltd.
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma	NCT06340204	Ewing Sarcoma	Irinotecan Hydr...	8 Years - 40 Years	Peking University People's Hospital
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma	NCT06340204	Ewing Sarcoma	Irinotecan Hydr...	8 Years - 40 Years	Peking University People's Hospital
Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma	NCT06430827	Biliary Tract C...	irinotecan hydr... Capecitabine	18 Years -	Peking Union Medical College Hospital
Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer	NCT04381910	Small Cell Lung...	LY01610( Irinot...	18 Years - 70 Years	Luye Pharma Group Ltd.

Spots Global Cancer Trial Database for irinotecan hydrochloride liposome injection