Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Apatinib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.

Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.

Jie Ma, doctor

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

Subjects were randomly divided into experimental and control groups. The experimental group was postoperatively treated with apatinib combined with capecitabine for adjuvant therapy of biliary cancer, and the control group was treated with capecitabine alone.

Progression free survival (PFS), overall survival (OS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), EORTC QLQ-C30, HCC-18 and drug safety: vital signs, laboratory indicators, adverse event (AE), and serious adverse event (SAE), drug-related AE and SAE and their specific AE (such as hypertension, proteinuria, and hand-foot syndrome) were followed for research in the two groups to evaluate the efficacy and safety of the two regimens for the treatment of biliary tract cancer according to the standard of NCI-CTCAE V4.0.

A rigorous, randomized and prospective study was conducted to compare the efficacy and safety in treating biliary cancer between the combined use of apatinib mesylate plus capecitabine and capecitabine alone, with a view to improving the survival outcome and life quality of patients with biliary tract cancer.

A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study

the length of time during the recruiment and after the progression of the biliary cancer verified by imagine examination

the length of time during the recruitment and after the death of the patient

The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response cases

The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response, partial response and stable disease cases

First Affiliated Hospital of Guangxi Medical University

Deputy director

Disitamab vedotin

Immunoconjugates

Immunologic Factors

Disitamab Vedotin combined with Zimberelizumab

Treatment regimen: Disitamab Vedotin , 2.5mg/kg, intravenously D1, once every 14 days (Q2W), combined with Zimberelizumab, 240mg, intravenously D1, once every 14 days (Q2W).

Chen Xiaofeng

Overall Study Officials Xiaofeng

This is a multicenter, single-arm, open-labal, phase II clinical study with a planned enrollment of 31 patients with HER2-overexpressing unresectable locally advanced or metastatic biliary carcinoma who had failed previous treatment. The efficacy and safety of the study were evaluated according to RECIST V1.1.

The study included a screening period, a treatment period, and a follow-up period.

Screening period: Subjects who are fully aware of the study and have signed an informed consent form should complete all screening procedures within 28 days before the first dose. Only eligible subjects can be enrolled in the study. Prior to enrollment, subjects should provide a test report confirming HER2 overexpression, defined in this study as IHC 2+ or 3+. Official reports from local hospitals or genetic testing companies are acceptable. All subjects provided adequate tumor tissue samples (archived or fresh biopsy samples) for evaluation and confirmation of HER2 expression and genetic testing (15 paraffin sections, 5-10um thick) before study administration. Considering the accessibility of clinical specimens, specimens are not mandatory.

Treatment period: Each treatment period was 14 days. Treatment regimen: Disitamab Vedotin, 2.5mg/kg, intravenously D1, once every 14 days (Q2W), combined with Zimberelizumab, 240mg, intravenously D1, once every 14 days (Q2W). Study treatment will be continued until the subject has an intolerable toxic effect, withdrawal of informed consent, and disease progression as confirmed by RECIST V1.1 (when the subject has disease progression as assessed by the investigator according to RECIST V1.1, the investigator will then assess whether the subject still has clinical benefit. If the subject is considered to have continued clinical benefit and meets the criteria for continuing treatment after disease progression, the subject may continue to receive the study drug; Treatment may be discontinued if the subject is no longer considered to have clinical benefit), or any other termination criteria specified in the protocol, whichever comes first. Within the time window specified in each cycle, the subject will complete a physical examination, laboratory tests, and other tests to assess the subject's safety. Imaging evaluations of tumors were performed every 6 weeks (42±3 days) during study treatment. Tumor evaluation must include all known lesions in the abdomen, pelvis, and other sites. Scans of suspected lesions and bone may be performed at the investigator's discretion. The assessment methods used throughout the study should be as similar as possible. The preferred method is enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

Follow-up period: including safety follow-up and survival follow-up. At the end of treatment, all subjects will be followed up for safety until 28 days after the last dose. Subjects who discontinue treatment for reasons other than PD will be followed up at the planned frequency until PD occurs, consent is withdrawn, or follow-up is lost, whichever occurs first. After completion of treatment and safety follow-up, all subjects were followed for survival (OS data were collected every 3 months ±14 days) until death, withdrawal of informed consent, loss to follow-up, or termination of the study, whichever occurred first.

RC-48 Combined With GLS-010 in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer

Disitamab Vedotin（RC-48 ）Combined With Zimberelizumab（GLS-010） in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer，A Single-arm, Open-label, Phase II Clinical Trail（RIGHT Study）

Assessed by the investigator according to RECIST V1.1

AE, SAE, TRAE, irAE, AE leading to dose adjustment, AE leading to withdrawal from the trial, and laboratory data were summarized according to NCI-CTCAE V5.0

Stable disease (SD) should persist for ≥6 weeks as assessed by the investigator according to RECIST V1.1

The estimation was based on Kaplan-Meier (KM) method

The First Affiliated Hospital with Nanjing Medical University

Associate chief physician

TQB3454 tablets orally administered, 21 days as a treatment cycle.

Placebo tablets orally administered, 21 days as a treatment cycle.

TQB3454 is a selective IDH1 mutant enzyme inhibitor.

TQB3454 tablets

Placebo tablets without active substance.

TQB3454 tablets matching placebo

Lin Shen, Doctor of Medicine

Zhongtao Zhang, Doctor

Wence Zhou, Doctor

Zhiwu Wang, Doctor

Feng Shen, Doctor of Medicine

This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.

A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.

It refers to the time from randomization to the death from any cause.

It refers to the time from randomization to disease progression or death, whichever occurs first.

The time between the first disease progression and the second disease progression or death, whichever comes first.

The percentage of subjects with complete response (CR) or partial response (PR).

The percentage of subjects with complete response (CR), partial response (PR) and stable disease (SD).

The time from randomization to initiation of a new antitumor therapy or early termination of therapy.

It is an integrated system to describe the quality of life of cancer patients.

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events V5.0 (CTCAE 5.0)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Cholangiocarcinoma

Urinary Bladder Neoplasms

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Bile Duct Cancer

Gallbladder Cancer

Gemcitabine

Cisplatin

Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.

Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.

Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.

Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.

Copanlisib

Richard D. Kim, M.D.

The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): 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 mm. (Note: the appearance of one or more new lesions is also considered progression.)

Complete Response + Partial Response according to RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.

Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.

Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.

Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.

Combination Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants that received at least one dose of study drug

Richard Kim, MD, Principal Investigator

Progression Free Survival (PFS)

Partial Response

Stable Disease

Number of participants evaluable for response

Response Rate

Overall Survival (OS)

Overall Study

Gland and Hormone Related Diseases

Infections

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenoviridae Infections

Ovarian Cancer

Ovarian Epithelial Cancer

LOAd703 oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)

Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL

LOAd703

Angelica Loskog, PhD

This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary, colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum 50 patients can be enrolled.

LOAd703 is an immunostimulatory gene therapy using an selection replication competent adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter.

The trial is a Phase I/II trial evaluating the effect of LOAd703 in patients with pancreatic cancer, biliary cancer, ovarian cancer and colorectal cancer. LOAd703 is an oncolytic adenovirus serotype 5/35 encoding immunostimulatory transgenes: TMZ-CD40L and 41BBL. In Phase I, three doses (total viral load - 1x10e11, 5x10e11, 1x10e12 viral particles (VP)) of LOAd703 will be tested as add-on to standard of care or immune-conditioning gemcitabine chemotherapy. 8 treatments of LOAd703 will be delivered by image-guided intratumoral injection at the same time of chemotherapy. In Phase II stage of the study, patients will be treated at maximum tolerated dose/maximum tolerated study dose as defined in the Phase I stage. In both phases: tumor biopsies, blood samples and radiological imaging will be performed to evaluate safety, effect and mechanisms of action. Further, patients will be subjected to oral and rectal swabs, and urine sampling to determine virus shedding. The patients will be monitored for time to progression, progression free survival and overall survival.

Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer

Phase I/II Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer

Toxicity symptoms graded according to CTCAE v4.x.

Immune reactions to LOAd703 virus as assessed by anti-adenovirus Ig ELISA

Local and distant anti-tumoral size changes assessed by appropriate imaging accordingly to RECIST 1.1

Months of progression free survival from registration

Cytokine relative increase in blood evaluated by cytokine array

Upregulation of activation marker compared to baseline (fold change) evaluated by flow cytometry

LOAd703 virus particles (vp) detected in blood (VP/ml) investigated by quantitative PCR at several time points before and after LOAd703 virus treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma	NCT03609489	Biliary Carcino...	Capecitabine Apatinib	18 Years - 75 Years	First Affiliated Hospital of Guangxi Medical University
RC-48 Combined With GLS-010 in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer	NCT05540483	Biliary Carcino...	Disitamab Vedot...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.	NCT05987358	Biliary Carcino...	TQB3454 tablets TQB3454 tablets...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma	NCT02631590	Biliary Carcino... Gall Bladder Ca... Cholangiocarcin... Gastrointestina...	Cisplatin Gemcitabine Copanlisib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer	NCT03225989	Pancreatic Aden... Ovarian Cancer Biliary Carcino... Colorectal Canc...	LOAd703	18 Years -	Lokon Pharma AB
Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer	NCT03225989	Pancreatic Aden... Ovarian Cancer Biliary Carcino... Colorectal Canc...	LOAd703	18 Years -	Lokon Pharma AB
RC-48 Combined With GLS-010 in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer	NCT05540483	Biliary Carcino...	Disitamab Vedot...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma	NCT03609489	Biliary Carcino...	Capecitabine Apatinib	18 Years - 75 Years	First Affiliated Hospital of Guangxi Medical University
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.	NCT05987358	Biliary Carcino...	TQB3454 tablets TQB3454 tablets...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for biliary carcinoma