Neoplasms

All Conditions

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

Micronutrients

Bevacizumab

Leucovorin

Fluorouracil

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

HAIC Combined With Sintilimab and Bevacizumab Biosimilar

hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

HAIC

Sintilimab

Bevacizumab Biosimilar

Huikai Li, MD

To Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in the Treatment of Patients With Unresectable Hepatocellular Carcinoma.

HAIC Combined With Sintilimab and Bevacizumab Biosimilar for Unresectable HCC

A Study to Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in Unresectable Hepatocellular Carcinoma.

Defined as proportion of patients who have a best response of CR or PR

Defined as the time from the date of treatment start to the date of death

Defined as the time from enrollment to disease progression, recurrence or death (whichever occurs first)

Defined as the incidence rate of patients that receive surgical resection.

Defined as the proportion of patients undergoing radical resection to the total patients accepted surgical resection

Defined as the proportion of patients whose tumor and lymph node completely disappeared to the total patients accepted surgical resection

Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 and complications of surgery

Tianjin Medical University Cancer Institute and Hospital

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Paclitaxel

Albumin-Bound Paclitaxel

albumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks

albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity

albumin-bound paclitaxe combined with bevacizumab biosimilar

Beihua Kong

Beihua Kong, MD. PhD.

The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.

Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer

Efficacy and Safety of Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer：A Multi-center, Prospective, One-arm, Phase II Study

Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR

the percentage of participants with no progression event at 6 months after starting study treatment

PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first

Overall survival is defined as the time from treatment start until death from any cause

the percentage of complete and partial response as well as stable disease

Shandong University

Head of gynaecology and obstetrics

Chlorotrianisene

TACE Combined With Sintilimab Plus Bevacizumab Biosimilar

1-4 cycles, intra-arterial infusion: sindilimab 200mg + bevacizumab 7.5mg/kg, q3w; 5-18 cycles: Sintilimab (200mg ivdrip D1 Q3W)+Bevacizumab Biosimilar (15mg/kg ivdrip D1 Q3W）

Sintilimab; Bevacizumab Biosimilar

Fei Gao, M.D.

Zhenkang Qiu, M.D.

Fei Gao, PhD, MD

Zhenakng Qiu, MD

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).

This is a prospective, single arm, phase II study to evaluate the efficacy and safety of TACE combined with Sintilimab and Bevacizumab Biosimilar (T-Double Therapy) in patients with HCC (BCLC-C Stage). Subjects who meet the admission criteria will be treated with Sintilimab and Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued.

The primary outcome measure is to evaluate the objective response rate (ORR) of T-Double Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of T-Double Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of T-Double Therapy for advanced HCC.

TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study

Sun Yat-sen University Cancer Center

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST.

DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST

The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST.

OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

Sun Yat-sen University

Chief physician

TACE Combined With Bevacizumab Biosimilar

TACE + Bevacizumab (15mg/kg, intra-arterial infusion, Q3W) for 4 cycles, followed by maintenance therapy with Bevacizumab (15mg/kg, intravenously, Q3W) to a maximum total cycle of 18 unless any evidence of disease progression or unacceptable side effects.

Bevacizumab Biosimilar QL 1101

Fei Gao, Ph.D., M.D.

Han Qi, M.D.

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria.

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of TACE combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria. Subjects who meet the admission criteria will be treated with Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, patient withdrawal or the investigators determine that the drug must be discontinued.

The primary outcome is the objective response rate (ORR). The secondary outcomes include the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events of TACE combined with anti-VEGF (Bevacizumab Biosimilar) for HCC (BCLC-B stage) beyond up-to-seven criteria.

TACE Combined With Bevacizumab in HCC (BCLC-B) Beyond Up-To-Seven Criteria

TACE Combined With Bevacizumab in Patients With BCLC-B Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria: a Prospective Single-arm Phase II Study

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST.

The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIS.

ase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

Bevacizumab biosimilar: 15mg/kg, IV, Q3W, D1

Huichuan Sun

This is a Phase Ib study to evaluate the safety and efficacy of sintilimab combined with bevacizumab biosimilar in patients with potentially resectable intermediate hepatocellular carcinoma (HCC).

Sintilimab Combined With Bevacizumab Biosimilar for Potentially Resectable Intermediate HCC

An Exploratory Study of Sintilimab in Combination With Bevacizumab Biosimilar in Patients With Potentially Resectable Intermediate HCC

Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system

Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate)

Defined as the proportion of patients who had pathological response.

Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first, assessed up to 2 years post-treatment

Defined as the time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive.

Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HAIC Combined With Sintilimab and Bevacizumab Biosimilar for Unresectable HCC	NCT05029973	Hepatocellular ...	HAIC Sintilimab Bevacizumab Bio...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer	NCT04670978	Objective Respo...	albumin-bound p...	18 Years - 70 Years	Shandong University
TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study	NCT04796025	Hepatocellular ...	Sintilimab; Bev...	18 Years - 69 Years	Sun Yat-sen University
TACE Combined With Bevacizumab in HCC (BCLC-B) Beyond Up-To-Seven Criteria	NCT05883176	Hepatocellular ...	Bevacizumab Bio...	18 Years - 70 Years	Sun Yat-sen University
Sintilimab Combined With Bevacizumab Biosimilar for Potentially Resectable Intermediate HCC	NCT04843943	Hepatocellular ...	Sintilimab Bevacizumab Bio...	18 Years - 75 Years	Fudan University
Sintilimab Combined With Bevacizumab Biosimilar for Potentially Resectable Intermediate HCC	NCT04843943	Hepatocellular ...	Sintilimab Bevacizumab Bio...	18 Years - 75 Years	Fudan University
TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study	NCT04796025	Hepatocellular ...	Sintilimab; Bev...	18 Years - 69 Years	Sun Yat-sen University

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