Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

SG001 injection

Bevacizumab injection

SG001 placebo

Fenglin She, MSc

Lingying Wu, M.D

This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.

The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.

The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).

Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer

Incidence and grade of the TRAE、SAE and irAE

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Neuroepithelioma

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Endothelial Growth Factors

Mitogens

On the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes).

On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes).

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Bevacizumab injection（Avastin）

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.

A Phase I Clinical Trial of Bevacizumab Injection

A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers

Area under the blood concentration time curve from 0 hour to the collection time t of the last measurable concentration

Area under the blood concentration time curve from 0 hour to inf (infinity)

Maximum plasma concentration observed after administration

Incidence of adverse events assessed by CTCAE v4.0

Number of adverse events evaluated by CTCAE v4.0

Incidence of study drug-related adverse events assessed by CTCAE v4.0

When anti drug antibody (ADA) is positive, neutralizing antibody (NAB) test is performed

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Adenocarcinoma

Adenocarcinoma of Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Docetaxel

Nedaplatin

The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs.

Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs.

Bevacizumab Injection

The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.

chest radiation

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

concurrent chemotherapy

Bo Qiu, Attending

Hui liu, Professor

Hui Liu, Professor

This prospective phase II study is determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes

This prospective phase II study is determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes.

The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Bevacizumab and Radiotherapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

A Single-Armed Phase II Study of Radiation and Bevacizumab Maintenance Therapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

Sun Yat-sen University

Professor

Nervous System Diseases

Diffuse Intrinsic Pontine Glioma

Brain Stem Neoplasms

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Low-dose concurrent Bevacizumab with standard radiotherapy

Additional concurrent low-dose Bevacizumab with standard EBRT

Ultra-low-dose EBRT instead of standard dose RT

Ultra-low-dose RT

Rahul Krishnatry, Dr

Dr Rahul Krishnatry, MD

In this study, the investigators are testing improvement in survival outcomes in DIPG patients when stratified with MR perfusion score and treated with the said protocol. Newly diagnosed DIPG patients will undergo MRI perfusion study in addition to the usual MRI at diagnosis and will be stratified into hyperperfused or hypoperfused tumours.

The hyperperfused patients will receive additional low dose Bevacizumab weekly with conventional standard radiotherapy.

The hypo-perfused patients will receive ultra-low-dose radiotherapy fractionation equivalent to conventional RT biological dose.

In tumours like Diffuse pontine glioma (DIPG), the diagnosis itself spells a death sentence for the child affected. The current standard treatment is conventionally fractionated daily radiation treatment for 6 weeks which benefits 80-90% patients with temporary improvement in neurological function which gives survival up to 8-10 months. With research over several decades, none of the altered fractionation radiotherapy or additional chemotherapy or targeted agents has shown a significant difference in outcomes.

The investigators propose to do an MRI perfusion study in addition to usual MRI at diagnosis and stratify them into hyperperfused or hypoperfused based on the criteria from the investigator's previously published institutional experience in DIPG. The hyperperfused patients will receive additional low dose a drug called Bevacizumab weekly with conventional standard radiotherapy. It is hypothesized that low dose Bevacizumab will decrease hypoxia and improve the efficacy of conventional radiotherapy and in turn improve outcomes.

The hypo-perfused patients will receive ultra-low-dose radiotherapy fractionation equivalent to conventional RT biological dose. As it is assumed that hypoperfused tumours are radioresistant, the investigator hypothesis that the ultra-low dose radiotherapy may overcome that radioresistance as seen in GBM adult patients and may improve outcomes.

A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma

Survival for the total enrolled patient population will calculated at the median follow up 12 months. This will be compared with historical data from TMH, international DIPG registry and SIOP DIPG registry for 12-month OS as 35%.

Progression-free survival: at 6 months, 12 months, 18 months will be recorded for overall cohort and each arm separately at first progression only. For the purpose of the study, any patient with two or more new clinical signs of neurological deterioration in accordance with classical DIPG diagnosis with radiological progression of disease from any previous available imaging will be called progression.

The documentation of highest grade of toxicity as per CTCAE v 4 and RTOG radiation toxicity.

Total duration of steroid use will be recorded

local versus disseminated progression will be documented for each arm and overall cohort for the patients with available MRI at progression.

Overall survival in each arm as well as for overall cohort will be recorded

Treatment intervention abandonment rates: number of patients not completing the planned intervention/treatment.

average number of hours spent in hospital per day during the intervention phase.

The Qol scores will be calculated as per the routine OPD based collection of Health using utilities index (40 item standard questionnaire) and/or PedQol interviewer based scores.

Tata Memorial Centre

Immunologic Factors

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).

Recombinant humanized anti-PD-1 monoclonal antibody injection

the usage and dosage should be determined by the investigator

Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)

carboplatin

Paclitaxel for Injection

Juan Chen

Zhaohe Wang, Ph.D

Qinglei Gao, Ph.D

Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer

The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of the study drug will include 20-50 subjects to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will be conducted after the inclusion of 20 subject. If the safety of this combination regimen is manageable and the efficacy meets expectations, the enrollment in the Phase II study will be stopped and the Phase III study will be entered. The Phase III study is a randomized, double-blind, multicenter clinical study of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a superiority design will be adopted with a total sample size of 476 subjects. Stratified block randomization will be performed based on the following random factors: patients will be stratified based on the presence of metastatic diseases at the time of diagnosis (Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).

BAT1308 Combined With Platinum-Based Chemotherapy± Bevacizumab For PDL1-Positive (CPS ≥1) Cervical Cancer

A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined With Platinum-Based Chemotherapy ± Bevacizumab as First-Line Therapy For PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer

Safety endpoints: Number of participants with abnormal vital signs

Safety endpoints: Number of participants with abnormal physical examination

Safety endpoints: Number of participants with various adverse events (AEs)

Safety endpoints: Number of participants with abnormal clinical laboratory tests

Safety endpoints: Number of participants with abnormal clinical auxiliary tests

Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1)

Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1).

Safety endpoints: Number of participants with abnormal various adverse events (AEs)

Safety endpoints:Number of participants with abnormal clinical auxiliary tests

Bio-Thera Solutions

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

Leucovorin

Fluorouracil

Irinotecan

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib Mesylate Tablets 250mg po qd Irinotecan 180 mg/m2 IV over 30-90 minutes,day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion,day 1 5-FU 400 mg/m2 IV bolus day 1,then 1200 mg/m2/d x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks.

Bevacizumab Injection 5mg/kg IV,day 1 Irinotecan 180 mg/m2 IV over 30-90 minutes,day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion,day 1 5-FU 400 mg/m2 IV bolus day 1,then 1200 mg/m2/d x 2days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks.

Apatinib combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC

Apatinib Mesylate Tablets

Bevacizumab combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC

Wan He, PhD,MD

Bevacizumab, an antibody against vascular endothelial generated factor (VEGF), combined with the fluorouracil-based chemotherapy regimens has been approved in the 1st and 2nd line treatments for metastatic colorectal cancers(mCRC). Other inhibitors of the VEGF pathway, such as Ramucirumab and Aflibercept are also approved in the 2nd line therapy. Apatinib is a small molecule tyrosine kinase inhibitor (TKI), which can highly selectively bind to and strongly block VEGF receptor 2 (VEGFR - 2), resulting in reduced cell migration, proliferation, and tumor microvascular density mediated by VEGF . In this study, the patients who have progressed following or on the first-line oxaliplatin and fluorouracil（5-FU） combined with bevacizumab are randomised into two arms(FOLFIRI plus apatinib or FOLFIRI plus bevacizumab) in the 2nd line setting. To identify specific biomarkers at the genetic and proteomic levels between two arms is the primary end point.

Based on inclusion and exclusion criteria, eligible mCRC patients are enrolled. the chest-abdonimal-pelvic CT with brain MRI and blood tests are examined to assess base-line measurable lesions and guarantee adequate organ function prior to enrollment. The written consents are signed before enrollment. Randomise patients into two arms: Arm A-apatinib plus FOLFIRI regimen and arm B-bevacizumab plus FOLFIRI regimen. Patients will be given full-dose drugs or reduced-dose drugs if serious toxicities ( CTCAE v4.0 criteria grade 3/4) are complained since previous cycle of treatment.

Symptoms and blood test results (including carcinoembryonic antigen（CEA）and CA199) before each cycle will be recorded. Radiological assessment consisting of chest-abdonimal-pelvic CT together with brain MRI will be performed every 3 months.

Collect biopsy specimens and peripheral blood from mCRC patients every 3 months since randomisation. Identify differential biomarkers between apatinib and bevacizumab and define these biomarkers' prognostic and predictive significances.

Head-to-head comparison of apatinib versus bevacizumab plus second-line chemotherapy regimen FOLFIRI for treatment of metastatic colorectal cancer

Biomarkers for Apatinib and Bevacizumab in Second-line Therapy for Colorectal Cancer(BABST-C)

The Biomarkers Identification for Apatinib and Bevacizumab in the Second-line Therapy for Colorectal Cancer: A Randomised Controlled Trial

Identify differentially expressed genes specific to apatinib or bevacizumab by the next-generation RNA-seq technology .

Identify proteomic molecules specific to apatinib or bevacizumab by the photoreactive crosslinking, pull-down, affinity purification and mass spectrometry (AP-MS) analyses

PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.

OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.

Shenzhen People's Hospital

Professor Wan He

Carcinoma, Hepatocellular

Liver Neoplasms

Liver Diseases

Nivolumab

Immune Checkpoint Inhibitors

nivolumab 480 mg IV infusions for 30 minutes q4w

The aie of this clinical study is the safety and efficacy of combination therapy for HCC patients.

Activation of anti-tumor immune response using programmed death receptor-1 (PD-1)blockade showed benefit only in a fraction of hepatocellular carcinoma (HCC) patients. Specific blockade of vascular endothelial receptor 2 (VEGFR-2) using a murine antibody significantly delayed primary tumor growth but failed to prolong survival. Combining PD-1 blockade with antiangiogenesis has shown promise in substantially increasing the fraction of HCC patients who respond to treatment in vitro. Based on these clinical data, we are aimed to investigation the safety and efficacy of combination therapy for HCC patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)	NCT05715840	Recurrent, or M...	SG001 injection Paclitaxel Cisplatin Carboplatin Bevacizumab inj... SG001 placebo	18 Years - 70 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Phase I Clinical Trial of Bevacizumab Injection	NCT05476341	Rectal Cancer Lung Cancer Ovarian Cancer Cervical Cancer Glioblastoma	Bevacizumab inj... Bevacizumab inj...	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Bevacizumab and Radiotherapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene	NCT03905317	Lung Adenocarci...	Bevacizumab Inj... chest radiation concurrent chem...	18 Years - 75 Years	Sun Yat-sen University
A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma	NCT04250064	DIPG	Bevacizumab Inj... Ultra-low-dose ...	3 Years - 18 Years	Tata Memorial Centre
BAT1308 Combined With Platinum-Based Chemotherapy± Bevacizumab For PDL1-Positive (CPS ≥1) Cervical Cancer	NCT06123884	Cervical Cancer	Recombinant hum... Cisplatin Bevacizumab Inj... carboplatin Paclitaxel for ...	18 Years - 70 Years	Bio-Thera Solutions
Biomarkers for Apatinib and Bevacizumab in Second-line Therapy for Colorectal Cancer(BABST-C)	NCT03743428	Colorectal Neop...	Apatinib Mesyla... Bevacizumab Inj...	18 Years - 75 Years	Shenzhen People's Hospital
Combination of PD-1 and VEGFR-2 Blockade for Advanced Hepatocellular Carcinoma	NCT04393220	Progress Free S...	Bevacizumab Inj... Nivolumab	18 Years - 70 Years	Fuda Cancer Hospital, Guangzhou
Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases	NCT03698162	Brain Metastase... Glioma of Brain Brain Tumor Metastatic Mela...	Dynamic Contras... Bevacizumab Inj...	21 Years -	University of Southern California
Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)	NCT05715840	Recurrent, or M...	SG001 injection Paclitaxel Cisplatin Carboplatin Bevacizumab inj... SG001 placebo	18 Years - 70 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Spots Global Cancer Trial Database for bevacizumab injection