Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Imatinib Mesylate

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Imatinib was given at dose of 400 mg twice daily continuously

Anlotinib Hydrochloride

Lu Xie, M.D.

Jie Xu, M.D.

Tingting Ren, Ph. D.

Wei Guo, M.D. and Ph.D.

For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.

Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

A Prospective, Multicentre, Open-label, Randomised Phase 2 Trial to Study the Efficacy and Safety of Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

CR+PR in the intent-to-treat population according to RECIST, version 1.1

Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation

OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation.

Peking University Shougang Hospital

Peking University Third Hospital

Peking University First Hospital

Beijing Jishuitan Hospital

Chinese PLA General Hospital

Peking University Cancer Hospital & Institute

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Peking University People's Hospital

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Extranodal NK-T-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Extranodal Nasal NK/T Cell Lymphoma

Sintilimab

Jian-yong Li, Master

This is phase II study. Efficacy and safety evaluation of IBI308 in patients with relapsed/refractory extranodal NK/T cell lymphoma, nasal type: a multicenter, single arm.

Extranodal NK/T cell lymphoma, nasal type(ENKTL) accounts for about 6% of all lymphomas in china. Epstein Barr virus (EBV) infection is found in all cases of ENKTL and maybe plays an important pathogenetic role.

Conventional anthrocycline-based regimens are not preferred to be used in ENKTL because of high p-glycoprotein expression. ORR of L-asparaginase based regimens is about 80% and no salvage regimens are recommended in ENKTL so far after failure of L-asparaginase based regimen.

Recently, a phase II clinical trial result demonstrated high ORR of anti-PD-1 antibody treatment in ENKTL.IBI308, a humanized monoclonal antibody (mAb) directly against PD-1, is investigated in this phase II Chinese ENKTL clinical trial.

Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese ENKTL subjects will also be assessed.

Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients

Efficacy and Safety Evaluation of IBI308 in Patients With Relapsed/Refractory Extranodal NK/T Cell Lymphoma, Nasal Type: a Multicenter, Single Arm, Phase 2 Study (ORIENT-4)

The tumor assessment is according to Lugano 2014 Criteria and then International Working Group (IWG) 2007 Criteria after 24 weeks. Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment (per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks). The primary efficacy endpoint is ORR evaluated using the 2014 Lugano Criteria before first progression disease (PD).

PFS was defined as the time from the first dose to the first documented progressive disease (PD) per Lugano 2014 or death due to any cause, whichever occurred first. Participates who neither progress nor die were censored at the date of their last tumor imaging evaluation. Participates who did not have any tumor imaging evaluation after baseline were censored on the date of enrollment.

DOR was defined as the time from first date of response to first PD per Lugano 2014 or death. Subjects who neither progress nor die were censored at the date of their last tumor imaging evaluation.

Innovent Biologics (Suzhou) Co. Ltd.

Safety Population: all the participants who received at least one dose of the investigational drug.

Sintilimab (IBI308)

Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

Yi Bo

Objective Response Rate (ORR) Before First PD

Progression Free Survival (PFS)

Duration of Response (DOR)

Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg intravenous infusion (IV) every 3 weeks (Q3W).

Overall Study

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Decitabine

Antimetabolites

Enzyme Inhibitors

Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

1. Number of Cycles: 4 cycles.
2. Dose and drug delivery(decitabine):

The 1st cycle: 20 mg/m2, (iv,\>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle.

If bone marrow blast cells\<5%, the following cycle:decitabine 20 mg/m2, (iv,\>1h) on d1-5 of each 28 day cycle.

If Grade 4 neutropenia（\<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,\>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（\<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,\>1h, on d1-3 of each 28day cycle).

Jianxiang Wang, MD

The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.

The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.

Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients

Xian-Janssen Pharmaceutical Ltd.

Jianxiang Wang

deputy director

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Substance Related Disorders

Pain, Postoperative

Urinary Bladder Neoplasms

Postoperative Complications

Pain

Neurologic Manifestations

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Analgesics

Central Nervous System Depressants

Antitussive Agents

Respiratory System Agents

Anti-Obesity Agents

Vasoconstrictor Agents

Morphine

Methadone

Analgesics, Opioid

Narcotics

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.

A 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.

One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.

One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.

The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.

During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device. Unfortunately, repeated doses or boluses of shorter-acting opioids, such as morphine, oxycodone and fentanyl, result in fluctuating blood concentrations, with the inherent risk of only relatively brief periods of adequate pain relief. Moreover, the use of shorter-acting opioids increases the risk of opioid-associated side effects, such as sedation, nausea and vomiting. An alternative approach to the postoperative use of shorter-acting opioids is therefore called for.

In this respect, methadone is an opioid with unique pharmalogical properties that may be advantageous when applied intraoperatively. A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids

Method:

110 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: intervention arm (methadone 0.15 mg/kg ideal body weight). Control arm (morphine 0.15 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2020041652) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-275-19).

Hypothesis We hypothesize that a single-dose of intravenous intraoperative methadone is efficient and safe for the treatment of postoperative pain after cystectomy.

Objectives The primary objective is to determine whether a single-dose of intravenous methadone reduces postoperative opioid consumption when compared to morphine. The secondary objectives are to compare the effect and safety of intravenous methadone and morphine on postoperative pain, side effects, patient satisfaction and length of stay.

Randomization and medication will be handled by hospital pharmacy. Randomisation list will be concealed until all statistical analyses are made.

* plan for data analysis was decided upon at a meeting with a statistician on September 7th, 2023. The plan was made before A and B lists were obtained from the hospital pharmacy. This study will be undertaken as an equivalence trial with the application of intention to treat analysis. Missing data are assumed to be missing at random. Primary outcome will be analyzed paired or unpaired t-test for difference, depending on distribution. Analysis of secondary outcome NRS will be reported as median(interquartile range) and compared between groups at the various times using the Mann-Whitney U test. If normal distributed multilevel mixed effects linear regression will be carried out. Analysis of other secondary outcomes will be dichotomized and presented for 3 and 24 hours with X2 test.

Methadone in Cystectomy Patients

Clinical Effectiveness and Safety of Intraoperative Methadone in Patients

• Pain intensity (NRS, 0-10) at rest and coughing, questionnaires answered by nurse.

• Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe). Questionnaires answered by nurse.

Gastrointestinal function (flatus, stools) and laxatives ordained.

• Opioid consumption within the first 3 hours after extubation

• Opioid consumption within the first 24 hours after extubation

NRS (0-10) at rest and when coughing. Questionnaires answered by nurse.

• Opioid consumption within the first 72 hours after extubation

Level of sedation (Ramsey Sedation Score) assessed by PACU nurse.

Patient satisfaction with pain management (NRS 0-10) Questionnaires answered by nurse.

• Time from arrival to discharge from PACU and hospital (hours and minutes)

University of Aarhus

Digestive System Diseases

Carcinoma

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Fluorouracil

Cisplatin

Taxane

Patients who had chemoradiotherapy before surgery.

Patients who had chemotherapy before surgery.

Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Neoadjuvant chemoradiotherapy

Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Oesophagectomy

Neoadjuvant chemotherapy

Herui Yao, PhD

Haiyu Zhou, PhD

Michael Lanuti, PhD

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.

DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause

R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).

pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.

Guangdong Provincial People's Hospital

Massachusetts General Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Principal Investigator

Skin and Connective Tissue Diseases

Osteosarcoma

Disease Progression

Disease Attributes

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Ifosfamide

Isophosphamide mustard

Antineoplastic Agents, Alkylating

Alkylating Agents

In the dose-defining phase I portion, camrelizumab was given at a fixed dose of 200mg Q2W, while the de-escalated 3+3 design was used to detect the recommended dose of famitinib from an initial level of 15mg orally taken daily. Recommended phase 2 dose (RP2D) was defined as the highest dose at which no more than 30% patients experience a DLT in the first two courses.

In the phase II portion, famitinib will be orally taken daily with RP2D together with camrelizumab intravenous infusion at a dose of 200 mg over 30 minutes, once every two weeks (Q2W), 4 weeks (28 days) as one treatment cycle.

Only phase II portion (Phase I have been completed): famitinib will be 20mg orally taken daily, 4 weeks (28 days) as one treatment cycle.

Only phase II protion (Phase I have been completed): famitinib will be 20mg orally taken daily, 4 weeks (28 days) as one treatment cycle together with ifofamide 1800 mg/m\^2/day intravenous infusion will be administered on Days 1 to 3 and 15-17 of each 28-day cycle for a total of 5 cycles.

Famitinib

ifosfamide 1.8g/m2/d d1-3, 15-17 Q4W infusion

Camrelizumab

Wei Guo, Ph.D. and M.D.

Results of previous study showed high objective response but short-term activity of anti-angiogenesis tyrosine kinase inhibitors in advanced osteosarcoma. Given the recent success of immunotherapies, combinations of antiangiogenics with immune checkpoint blockers have become an attractive strategy. The investigators had completed an prospective phase 2 trial of the combination of apatinib and camrelizumab on advanced osteosarcoma and showed prolonged progression-free survival for this combination. Famitinib is a novel tyrosine kinase inhibitor targeting VEGFR-2, -3 and FGFR-1, -2, -3, -4 with high affinity, which showed broad antitumor activity against a variety of xenograft models.

A Study to Compare the Efficacy and Safety of Levatinib with or without Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma showed promising median PFS of 11.3 months. Thus we also try to investigate the combination efficacy of TKIs with chemotherapy in advanced osteosarcoma.

This study aims to investigate the recommended phase 2 dose for pediatric use of famitinib in combination with camrelizumab and trys to explore the efficacy and safety for single drug famitinib, famitinib and camrelizumab and famitinib and ifosfamide in patients with inoperable high-grade osteosarcoma progressing after chemotherapy.

Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma

Famitinib Malate (SHR1020) Plus Camrelizumab (SHR 1210) Versus Famitinib Malate Alone Versus Famitinib Malate Plus Ifosfamide Locally Advanced, Unresectable or Metastatic Osteosarcoma Progression Upon Chemotherapy: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial

Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation.

Overall survival is was defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation. randomisation to the first occurrence of progression of disease orrandomisation.

Duration of response is defined as from the time of occurence of best overall response to progression or death for the proportion of patients achieving an overall response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma	NCT04042597	Effect of Drugs Quality of Life Chordoma Advanced Cancer	Anlotinib Hydro...	18 Years -	Peking University People's Hospital
Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients	NCT03228836	Effect of Drugs	Sintilimab	18 Years - 70 Years	Innovent Biologics (Suzhou) Co. Ltd.
Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients	NCT01633099	Untreated Adult... Effect of Drugs Drug Safety	Decitabine	60 Years -	ChineseAMS
Methadone in Cystectomy Patients	NCT04475029	Pain, Postopera... Postoperative C... Pathologic Proc... Bladder Cancer Pain Signs and Sympt... Neurologic Mani... Neurologic Symp... Side Effect of ...	Methadone Morphine	18 Years - 110 Years	University of Aarhus
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Methadone in Cystectomy Patients	NCT04475029	Pain, Postopera... Postoperative C... Pathologic Proc... Bladder Cancer Pain Signs and Sympt... Neurologic Mani... Neurologic Symp... Side Effect of ...	Methadone Morphine	18 Years - 110 Years	University of Aarhus
Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma	NCT04044378	Effect of Drugs Progression Pediatric Cance...	Famitinib Ifosfamide Camrelizumab	12 Years -	Peking University People's Hospital
Remifemin Preventing the Climacteric Symptoms in Breast Cancer	NCT03339882	Effect of Drugs Safety Issues	Remifemin	18 Years - 55 Years	Zhejiang Cancer Hospital
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma	NCT04042597	Effect of Drugs Quality of Life Chordoma Advanced Cancer	Anlotinib Hydro...	18 Years -	Peking University People's Hospital

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