Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

LBL-024+Etoposide+Cisplatin/Carboplatin Injection , dose A or dose B; Q3w

Initial dose - MTD; Q3W; intravenous infusion

LBL-024 for Injection

Etoposide Injection

Cisplatin for Injection

Carboplatin Injection

ling zang

xue kong

Xue Kong

lin shen

An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)

This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation phase and Phase II is a dose-expansion phase.

Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.

To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method.

Phase II program to enroll approximately 50 patients with advanced neuroendocrine carcinoma without systemic treatment.

This trial will enroll 68 patients in Phase Ib and Phase II study.

A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)

ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .

DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.

MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase Ib .

After taking a single dose, Time to reach maximum plasma concentration

The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects

The period from the participants first achieving CR or PR to disease progression.

Nanjing Leads Biolabs Co.,Ltd

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

all subjects will receive study treatment in 21-day cycle, Surufatinib 250mg, QD and Toripalimab, 240mg, IV drip, Q3W, D1, the treatment will continue until one of the following conditions occurs: progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first

FOLFIRI group subjects will receive study treatment in 14- day cycle, Irinotecan: 180 mg/m\^2, iv drip over 30～90 minutes, on Day 1; Calcium folinate: 400 mg/m\^2, iv drip for about 2 hours, given upon completion of infusion of Irinotecan on Day 1; 5-FU: 400 mg/m\^2, iv bolus, given upon completion of infusion of Calcium folinate on Day 1, followed by 2400 mg/m\^2 continuously iv drip for 46～48 hours.

Surufatinib is a tablet in the form of 50mg, oral, once a day; Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.

Surufatinib plus Toripalimab

Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-FU total 2800 mg/m\^2 will be administrated once two weeks.

5-fluorouracil, Calcium folinate and Irinotecan

Panfeng Tan

Lin Shen, Prof.

To evaluate the efficacy of Surufatnib combined with Toripalimab compared with FOLFIRI in the treatment of advanced neuroendocrine carcinoma

This is a randomized, controlled, open-label, multicenter, phase III clinical study designed to evaluate the efficacy and safety of surufatnib combined with toripalimab compared with FOLFIRI in patients with advanced neuroendocrine carcinoma who have progression of disease or intolerable toxicity after previous 1st-line chemotherapy.

A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma

A Phase 3, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Surufatinib Plus Toripalimab Versus FOLFIRI as a Secondline Treatment in Patients With Advanced Neuroendocrine Carcinoma

Duration from the date of initial treatment to the date of death due to any cause.

A duration from the date of initial treatment to disease progression or death of any cause.

The incidence of confirmed complete response or partial response

Duration from the first time reported partial response or complete response to the first time of disease progression or death.

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

To evaluate the relationship between the efficacy and tumor biomarkers of PD-L1

To evaluate the relationship between the efficacy and tumor biomarkers of ki67

The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

Hutchison Medipharma Limited

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Lung Neoplasms

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Stomach Neoplasms

Breast Neoplasms

Syndrome

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Glioblastoma

Small Cell Lung Carcinoma

Preleukemia

Myelodysplastic Syndromes

Anus Neoplasms

Carcinoma, Small Cell

Carcinoid Tumor

Colorectal Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Male Urogenital Diseases

Pancreatic Diseases

Stomach Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Small Cell Lung Cancer

Germ Cells Tumors

Anal Cancer

Malignant Germ Cell Tumor

Patients continue receiving their SOC chemotherapy regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Clinical Encounter

Home Health Encounter

Quality-of-Life Assessment

Questionnaire Administration

Clinical Trials Referral Office

Roxana S. Dronca, M.D.

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

PRIMARY OBJECTIVE:

I. To compare mean patient-reported rating of Cancer Connected Access and Remote Expertise (CARE) using a modified question from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey after 8 weeks between patients randomized to receive care at home and care in the clinic.

SECONDARY OBJECTIVES:

I. To evaluate patient preference for location of cancer treatment administration, at the infusion center or in the home.

II. To evaluate level of comfort with receiving infusions at home based on the following measures after 24 weeks of treatment (or at end of study):

IIa. The proportion of patients who indicate a preference for home infusion or no preference versus outpatient infusion unit administration of cancer treatment as assessed via the Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite a bit or very much) with receiving infusions at home as assessed by the Patient Preference Questionnaire.

III. To describe other patient experience questions within the Patient Preference Questionnaire after 24 weeks of treatment (or at end of study).

IV. To describe whether patients felt that infusions at home was worthwhile, would do it again, and recommend it to others after 24 weeks of treatment (or at end of study) using the Was It Worth It questionnaire.

V. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported function and global health/quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VI. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported symptoms as measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VII. To assess the safety of cancer directed therapy when administered at home by a home health provider with remote patient monitoring and Command Center support, based on the incidence, nature, and severity of the following:

VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to standard in clinic administration in the proportion of patients with an emergency room visit or hospitalization at the end of 6 months of study treatment.

IX. Overall survival.

EXPLORATORY OBJECTIVES:

I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To evaluate administration of treatment based on clinical practice data.

OUTLINE:

Patients receive the first 2 cycles of their standard of care (SOC) chemotherapy regimen in the clinic in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 2 arms.

ARM A: Patients continue receiving their SOC chemotherapy regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the Home Health Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls (CCBW) Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study intervention, patients are followed for 1 year.

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing "your overall cancer care experience". Will be compared between arms using a two-sample t-test.

The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.

Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.

Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others.

Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots.

Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade \>=1 AE during the first 8 weeks. The proportion of patients with at least one grade \>= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated.

Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots.

The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test.

The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.

Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma	NCT06157827	Advanced Neuroe...	LBL-024 for Inj... Etoposide Injec... Cisplatin for I... Carboplatin Inj...	18 Years - 75 Years	Nanjing Leads Biolabs Co.,Ltd
A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma	NCT05015621	Advanced Neuroe...	Surufatinib plu... 5-fluorouracil,...	18 Years - 75 Years	Hutchmed
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer	NCT05969860	Advanced Anal C... Advanced Biliar... Advanced Bladde... Advanced Breast... Advanced Carcin... Advanced Cervic... Advanced Colore... Advanced Gastri... Advanced Gliobl... Advanced Head a... Advanced HER2 P... Advanced Lung C... Advanced Lung S... Advanced Malign... Advanced Malign... Advanced Neuroe... Advanced Ovaria... Advanced Pancre... Advanced Prosta... Advanced Prosta... Hematopoietic a... Multiple Myelom... Myelodysplastic...	Clinical Encoun... Home Health Enc... Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for advanced neuroendocrine carcinoma