Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min

camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG

camrelizumab

Xu-Feng Zhang, MD,phD

Rui Qu

Yi Lv, MD,PHD

Xiaogang Zhang, Phd

Yi Lyu, MD,phD

To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer

camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;

Camrelizumab Utilization on Patients With Advanced Liver Cancer

A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer

First Affiliated Hospital Xi'an Jiaotong University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

This study adopted a prospective, multicenter, observational design. From October 1, 2022, 100 patients with HER2-positive breast cancer scheduled to receive neoadjuvant therapy with pyrotinib were enrolled. The treatment regimen was determined according to the patient 's condition, physician' s treatment experience, evidence-based evidence and other factors to assess the clinical benefit (pCR, ORR) and safety of different neoadjuvant therapy modalities containing pyrotinib. Exploratory analysis was performed to investigate the correlation between the level of TMB and the pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib on intestinal flora.

Pyrotinib

Ying He, M.D.

Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.

Pyrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor that simultaneously acts on three targets, HER1, HER2, and HER4, and is stable, well tolerated, and easily penetrates the blood-brain barrier compared with macromolecular targeted drugs. In the phase II study of pyrotinib combined with capecitabine in HER2-positive breast cancer, the primary study endpoint ORR was 78.5%, and the investigator-assessed PFS reached 18.1 months with good safety; it was precisely by virtue of the phase II clinical study that the drug was preferentially approved by the State Drug Administration for marketing. During the four years of marketing, significant therapeutic effects have also been achieved in phase III clinical studies, such as the PHOEBE study and the PHENIX study; neoadjuvant treatment of patients with early and locally advanced HER2-positive breast cancer was approved for the PHEDRA study in 2022.

Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.

Plasma and serum samples were collected from patients receiving pyrotinib for circulating tumor DNA (ctDNA) sequencing to calculate tumor mutation burden (TMB), and stool samples were collected to detect intestinal flora DNA (carried out according to the actual situation of the participating sites).

Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer

No histological evidence of malignant tumor was found in the primary breast focus and armpit of neoadjuvant patients, or only carcinoma in situ (ypT0/is ypN0).

No histological evidence of malignant tumor was found in the primary breast lesions of neoadjuvant patients, or only carcinoma in situ (ypt0 /is).

Adverse events are described in terms of CTC AE 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Camrelizumab Utilization on Patients With Advanced Liver Cancer	NCT04487704	Advanced Hepato...	camrelizumab	18 Years -	First Affiliated Hospital Xi'an Jiaotong University
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer	NCT05561686	HER2-positive B...	Pyrotinib	18 Years - 65 Years	Hunan Cancer Hospital
Camrelizumab Utilization on Patients With Advanced Liver Cancer	NCT04487704	Advanced Hepato...	camrelizumab	18 Years -	First Affiliated Hospital Xi'an Jiaotong University
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer	NCT05561686	HER2-positive B...	Pyrotinib	18 Years - 65 Years	Hunan Cancer Hospital

Spots Global Cancer Trial Database for rws

Every month we try and update this database with for rws 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 rws

Every month we try and update this database with for rws 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 rws 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.