Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.

TQB2450

Yuan Kai Shi

YuanKai Shi

Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma

A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification

Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis).

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Neoplasm Metastasis

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Liver Extracts

Tubulin Modulators

Antimitotic Agents

Antimetabolites

This is an opened single-arm phase 2 study， the study drug includes Fruquintinib combine with Paclitaxel Injection and Gemcitabine.

The study will mainly explore the safety and tolerability of fixed-dose level of Fruquintinib (4 mg, continuous medication for 3 weeks and withdrawal for 1 week) combined with fixed-dose level of albumin paclitaxel and gemcitabine. The fixed dose of Fruquintinib is 4 mg, with a treatment cycle every 28 days. A 28-day observation window was used to explore the side effects of fruquintinib in the combined treatment of pancreatic cancer patients with liver metastases. Evaluable patients will be assessed for DLT within 28 days after the first administration of the study drug. The 24 patients enrolled in the follow-up group will mainly evaluate the initial efficacy of furquintinib combined with albumin paclitaxel and gemcitabine as the first-line standard treatment for patients with metastatic pancreatic cancer.

Fruquintinib,Albumin Paclitaxel,Gemcitabine

Xianjun MD Yu, PhD

Si Shi

XianJun Yu, M.D., Ph.D.

Xianjun Yu, M.D., Ph.D.

The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients.

Pancreatic cancer is the most deadly malignant tumor commonly found in the digestive system and is known as the king of cancer. According to the global cancer statistics released in 2018, there are about 458,900 new cases of pancreatic cancer worldwide each year, and the number of deaths due to pancreatic cancer each year is about 432,200. The data of pancreatic cancer collected by the National Cancer Center of China in 2019 showed that the incidence rate was 6.92 per 100,000, and new cases accounted for about 4.31% of all malignant tumors, ranking 10th; the case fatality rate was 6.16 per 100,000, with deaths every year It accounts for about 3.78% of all malignant tumors, ranking 7th. Compared with urban areas and rural areas, the morbidity and mortality have increased compared with previous years. The incidence of pancreatic cancer has been increasing year by year worldwide, and it is expected that by 2030, it will surpass colorectal cancer and breast cancer to become the second cancer-fatal tumor. Pancreatic cancer is extremely malignant, with a 5-year survival rate of only 9%, and its case fatality rate is basically equal to the incidence rate. The case fatality rate of pancreatic cancer may continue to rise, which will seriously threaten and affect human health.

The specific etiology and pathogenesis of pancreatic cancer are currently unclear, the early clinical manifestations are not obvious, the rapid development, the extremely high degree of malignancy, and the poor prognosis, all of which lead to the refractory and high mortality of pancreatic cancer. It is precisely because the early symptoms are not typical and the clinical signs are not obvious, most patients are already in the locally advanced stage or have distant metastases when they are diagnosed.In this case, the chance of surgical treatment is low and the effect is not ideal. 80% of pancreatic cancer patients are already in the inoperable advanced stage at the time of diagnosis, and more than 50% of them have found metastases at the time of diagnosis, and have lost the chance of radical surgery. The most common distant metastasis site is the liver. At present, for patients with liver metastases from pancreatic cancer, the standard treatment regimen in domestic and foreign guidelines is palliative treatment based on chemotherapy.

According to the latest updated treatment guidelines for metastatic pancreatic cancer by the American Society of Clinical Oncology (ASCO), the first-line chemotherapy regimen should be selected based on the patient's physical status. For patients with good physical status, a combination regimen may be considered, and patients with poor physical status should choose single-agent chemotherapy. Or the best supportive treatment. For those with good physical status, FOLFIRINOX, gemcitabine and paclitaxel are recommended; for patients with poor physical status, single-agent gemcitabine can be used. If tolerable, they can be combined with albumin paclitaxel or calciner under the guidance of an experienced oncologist. Petabine or erlotinib. Overall, the median OS of first-line chemotherapy did not exceed 12 months, and the median OS of second-line chemotherapy ranged from 3.3 to 9.9 months. Therefore, the overall treatment effect of pancreatic cancer was poor, and the median survival was only 6 months. For 8 months, the effect was not good. All major guidelines recommend the development of multi-center clinical studies to prolong patient survival and discover new effective drugs. In summary, actively exploring new comprehensive treatment strategies, breaking through treatment options for advanced pancreatic cancer, improving the survival time of patients with liver metastases of pancreatic cancer, and exploring the biological characteristics of liver metastases of pancreatic cancer are important clinical issues that urgently need to be resolved.

The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients

An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer

Fudan University

President of Shanghai Pancreatic Cancer Institute

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Diseases

Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)

As per the treating physicians discretion

Regorafenib (Stivarga, BAY73-4506)

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs).

Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.

Overall survival (OS) is defined as the time (days) from the start of regorafenib treatment to the date of death, due to any reason. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up

Progression-free survival (PFS) is defined as the time (days) from the start of regorafenib treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented

Time to progression (TTP) is defined as the time (days) from the start of regorafenib treatment to the first documented disease progression

Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standard

Duration of regorafenib treatment, defined by the time interval from the start of regorafenib treatment to the day of permanent discontinuation of regorafenib (including death)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma	NCT03800706	Safety and Effe...	TQB2450	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	NCT05168527	Pancreatic Canc...	Fruquintinib,Al...	18 Years - 80 Years	Fudan University
Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)	NCT03289273	Liver Neoplasms	Regorafenib (St...	-	Bayer

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