Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The investigators will extract total protein, DNA and RNA from PSC patients.

Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)

There is no plan to make individual participant data (IPD) available to other researchers.

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Anhui Medical University

Shanghai 10th People's Hospital

Professor

Carcinoma, Non-Small-Cell Lung

Lung Diseases

Thoracic Neoplasms

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Drugs: Toripalimab, 240mg (6ml)/bottle, ivgtt, d1, q3w, administration until PD or death, the longest use time is two years.

Drugs: Bevacizumab, 7.5mg/kg, ivgtt, d1, q3w,the longest use time is two years.

Drugs: Nab-paclitaxel, 260mg/m2,ivgtt,d1 or 130mg/m2,ivgtt,d1,8, q3w, up to six cycles.

Drugs: Carboplatin, AUC=4～5, ivgtt, d1, q3w, up to six cycles.

240mg, ivgtt, d1, every 3 weeks until disease progress or intolerable toxicity, up to 2 years of administration

Toripalimab

7.5mg/kg, ivgtt, d1, every 3 weeks, up to 2 years of administration

260mg/m2,d1 or 130mg/m2,d1,8, ivgtt, every 3 weeks, up to 6 cycles

Nab-paclitaxel

AUC=4～5, d1, ivgtt, every 3 weeks, up to 6 cycles

Juan Li, MD

This study aimed to evaluate the efficacy and safety of first-line Toripalimab combined with bevacizumab, nab-paclitaxel and carboplatin in the treatment of patients with advanced pulmonary sarcomatoid carcinoma.

Pulmonary sarcomatoid carcinoma(PSC) is a rare primary lung cancer, which belongs to the category of non-small cell lung cancer(NSCLC), accounting for about 0.3%-1.3% of lung cancers .Platinum-based combination chemotherapy is the standard adjuvant chemotherapy and palliative chemotherapy for NSCLC, and it is also commonly used for PSC. Advanced PSC has a low response rate to systemic chemotherapy and a short duration of curative effect. The primary progression rate of aggressive platinum-based chemotherapy is 60%-70%, showing that PSC is highly resistant to multiple chemotherapeutics. In recent years, the progress of targeting MET tyrosine kinase mutations has been relatively rapid, but most of the mutant PSCs targeting EGFR, KRAS, ALK, and BRAF V600E are case reports and there is no effective treatments. Immunotherapy has rewritten the treatment pattern of NSCLC. However, the current application of immunotherapy in PSC are mostly case reports. In immunotherapy, IMpower150 research data suggests that the combination of immunity and anti-angiogenesis + platinum-containing dual-agent chemotherapy can bring sustained OS benefits in NSCLC patients , and safety tolerated. However, PSC has moderate to high tumor mutation burden (TMB \>10 mutations/Mb). This high mutation rate may increase tumor immunogenicity, making immunotherapy a better treatment option. At the same time, VEGF, as a cytokine that promotes the growth and differentiation of vascular endothelial cells, plays a decisive role in promoting tumor neovascularization. In this regard, immunotherapy combined with anti-angiogenesis and chemotherapy is worth exploring in the treatment of PSC.

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin for Untreated Metastatic Pulmonary Sarcomatoid Carcinoma

A Single-arm Exploratory Clinical Study on the Efficacy and Safety of Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin for Untreated Metastatic Pulmonary Sarcomatoid Carcinoma

It is defined as the time interval from randomization of patients to disease progression or death, whichever comes first. There was no progress or the time of disease progression was not recorded when the trial was withdrawn, and the date of the last examination was used as the end date.

The proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.

The proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.

Defined as the time interval from randomization to death. If the patient continues to survive or his life or death is unknown, the date of death will be reviewed using the latest point in time when the patient is still alive.

AEs per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

Analysis of changes from baseline using the quality of life (QoL) instrument

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)	NCT04215913	Lung Cancer	The investigato...	18 Years - 70 Years	Shanghai 10th People's Hospital
Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin for Untreated Metastatic Pulmonary Sarcomatoid Carcinoma	NCT04725448	Pulmonary Sarco... Non-small Cell ... Lung Diseases Thoracic Neopla...	Toripalimab Bevacizumab Nab-paclitaxel Carboplatin	18 Years - 75 Years	Sichuan Cancer Hospital and Research Institute
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)	NCT04215913	Lung Cancer	The investigato...	18 Years - 70 Years	Shanghai 10th People's Hospital

Spots Global Cancer Trial Database for psc

Every month we try and update this database with for psc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for psc

Every month we try and update this database with for psc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for psc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.