Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cetuximab

Oxaliplatin

Antineoplastic Agents, Immunological

GEMOX (Arms 1 and 2), every two weeks:

Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h

Cetuximab (ErbituxÒ) (Arm B only) every two weeks:

(chemotherapy will be started one hour after the end of the cetuximab infusion).

Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes

Gemox, Cetuximab

David MALKA, MD

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.

The BINGO trial is an open-label randomized phase II study evaluating the efficacy and tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises ancillary translational research and functional imaging studies which aim to identify markers predictive for treatment efficacy in ABC.

All eligible pts will be randomized 1:1 to receive:

* Arm A: GEMOX alone every two weeks.
* Arm B: GEMOX + cetuximab every two weeks.

Randomization will be stratified according to:

1. tumor stage (locally advanced vs metastatic),
2. primary tumor location (gallbladder vs non-gallbladder),
3. prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy \[PDT\] or adjuvant chemotherapy vs none),
4. center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC) using biopsy or surgical material, at any time prior to inclusion into the study, but it is neither an inclusion/exclusion criterion nor a stratification factor.

Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.

Merck Serono International SA

Gustave Roussy, Cancer Campus, Grand Paris

Capecitabine

Antimetabolites

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.

TQB2450 Injection

Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Anlotinib hydrochloride

Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;

Oxaliplatin injection

Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;

Capecitabine tablets

Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Gemcitabine hydrochloride injection

Yueyin Pan, Doctor

Guangyu An, Doctor

Aiping Zhou, Doctor

Lei Chen, Doctor

Dondong Lin, Doctor

Lin Shen, Doctor

Jiahong Dong, Doctor

Xiaoyan Lin, Doctor

Aimin Zang, master

Jinghua Gao, bachelor

Qingshan Li, bachelor

Yanqiao Zhang, Doctor

Xiaobing Chen, Doctor

Hong Qiu, Doctor

Chuang Peng, Doctor

Haijiao Yan, Doctor

Wei Li, Doctor

This study is a randomized, parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer.

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer

A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Percentage of participants achieving complete response (CR) and partial response (PR).

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved complete or partial remission to disease progression.

Percentage of participants whose PFS has achieved at least 6 months.

Percentage of participants whose OS has achieved at least 6 months.

Percentage of participants whose OS has achieved at least 12 months.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Carcinoma

Cholangiocarcinoma

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

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

Gallbladder Neoplasms

Bile Duct Neoplasms

Micronutrients

Hematinics

Vitamins

Leucovorin

Fluorouracil

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

5-Fluorouracil (5-FU) Plus Leucovorin (LV)

Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle

becatecarin

5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle

5-Fluorouracil Plus Leucovorin

Afshin Dowlati, MD

The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin	NCT00552149	Advanced Biliar...	Gemox, Cetuxima...	18 Years - 75 Years	Gustave Roussy, Cancer Campus, Grand Paris
Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin	NCT00552149	Advanced Biliar...	Gemox, Cetuxima...	18 Years - 75 Years	Gustave Roussy, Cancer Campus, Grand Paris
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer	NCT04809142	Advanced Biliar...	TQB2450 Injecti... Anlotinib hydro... Oxaliplatin inj... Capecitabine ta... Gemcitabine hyd...	18 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
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors	NCT00090025	Biliary Tract C...	becatecarin 5-Fluorouracil ...	18 Years -	Helsinn Healthcare SA

Spots Global Cancer Trial Database for advanced biliary cancer