Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Donafenib Tosilate Tablets

Toripalimab Injection

Shanzhi Gu, MD

This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.

The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death

defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

donafenib tosilate tablets

Jianming Xu, Doctor

This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy .

The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival.

This open-label, noncomparative, two-part phase 1B trial recruited patients with advanced, inoperable oesophageal cancer. The primary objectives were to assess the safety for donafenib tosylate tablets .The secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(QoL); This study is 2-stages designing. The investigators plan to enroll 19 patients in the first stage study. The investigators will start the secondary stage study if the disease control rate \>=8/19.

A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy

Tumor evaluation by investigators according to RECIST 1.1 criteria

PFS was defined as the time from date of randomization to disease progression radiological or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.

Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.

ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).

ZG005 Powder for Injection

Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).

Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

Yongsheng Chu

Xiaoli Chai

This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.

Time from first dose of the investigational drug to PD or death from any cause.

Changsha Taihe Hospital

Anti-Obesity Agents

Vasoconstrictor Agents

Respiratory System Agents

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.

The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.

intravenous infusion(IV), once every 3 weeks

The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage

Cheng Wei

Bo Zhu

Jason Wu

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.

A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause

Time from the first evaluated CR or PR until PD or death from any cause

Donafenib 50mg BID/100 mg BID/200 mg BID orally + KN046 5mg/kg Q3W iv

In the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets \[50 mg twice a day; 100 mg twice a day; 200 mg twice a day \] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.

KN046 Injection

Tianshu Liu, PhD

Tianshu Liu

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.

The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.

A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors

Evaluated by severity of drug-related adverse events (AEs), serious adverse events (SAEs).

Objective response rate based on the RECIST 1.1 by investigator. Percentage of subjects achieving complete response (CR) and partial response (PR).

It is defined as time between the date of first radiographic documented objective response and the date of the radiographic documented disease progression.

PFS is defined as the time from date of enrollment to the date of the first objectively documented tumor progression or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma	NCT04605185	Unresectable He...	Donafenib Tosil... Toripalimab Inj...	18 Years - 75 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer	NCT02489201	Oesophageal Can...	donafenib tosil...	18 Years -	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma	NCT06233994	Advanced Hepato...	ZG005 Powder fo... Donafenib Tosil... Bevacizumab	18 Years -	Changsha Taihe Hospital
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor	NCT06239298	Solid Tumor	ZG005 Powder fo... Donafenib Tosil...	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors	NCT04612712	Advanced Gastro...	Donafenib Tosil... KN046 Injection	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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