Advanced Biliary CancerPhase 3NCT04809142
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer
A Phase 3 study testing TQB2450 Injection, Anlotinib hydrochloride and Oxaliplatin injection in people with Advanced Biliary Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Cancer
- What is being tested?
- TQB2450 Injection, Anlotinib hydrochloride and Oxaliplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 17 sitesChina
- Study dates
- 4 Feb 2021to 1 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
- 2.18 years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.5.
- 3. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.
- 5.Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.
Who cannot join
- 1. Tumor disease and medical history:
- Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- Has other malignant tumors within 5 years;
- Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
- Severe bone damage caused by tumor bone metastasis;
- Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;
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- Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved; 2. Previous anti-tumor therapy:
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- Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;
- Have received anti-tumor therapy within 4 weeks before the first administration;
- Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:
- <!-- -->
- Active hepatitis B or C;
- Kidney abnormalities;
- Abnormal thyroid function;
- Cardiovascular abnormalities;
- Gastrointestinal abnormalities;
- History of immunodeficiency;
- Has risk of bleeding;
- Uncontrollable active bacterial, fungal or viral infections;
- Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;
- Allergies to the ingredients of the study drug;
- Have a history of neurological or psychiatric disorders
- According to the researcher's point of view, other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study, or may interfere with the interpretation of the study results;
- Have a history of pituitary or adrenal dysfunction
- Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
- Long-term unhealed wound or fracture;
- Has drug abuse history that unable to abstain from or mental disorders; 4. Has participated in other clinical trials within 30 days before the study. 5. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
- 6. Pregnant or breastfeeding women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Aimin Zang, master, booszam@sina.com
Aimin Zang, master
- Not yet recruiting
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020
Guangyu An, Doctor, agybjcyyy@163.com
Guangyu An, Doctor
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Aiping Zhou, Doctor, 010-87788800, zhouap1825@126.com
Aiping Zhou, Doctor
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Lei Chen, Doctor, chenlei@pkuoh.edu.cn
Lei Chen, Doctor
- Not yet recruiting
Beijing Youan Hospital,Captical Medical University
Beijing, Beijing Municipality, 100069
Dondong Lin, Doctor, ldd1231@126.com
Dondong Lin, Doctor
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089
Lin Shen, Doctor, 010-88196340, doctorshenlin@sina.cn
Lin Shen, Doctor
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Jiahong Dong, Doctor, 010-56118888, dongjiahong@mail.tsinghua.edu.cn
Jiahong Dong, Doctor
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 061001
Jinghua Gao, bachelor, gaojinghua0317@163.com
Jinghua Gao, bachelor
- Not yet recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
Wei Li, Doctor, jdyylw@163.com
Wei Li, Doctor
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
Chuang Peng, Doctor, 1518364280@qq.com
Chuang Peng, Doctor
- Not yet recruiting
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000
Haijiao Yan, Doctor, haijiao8237@163.com
Haijiao Yan, Doctor
- Not yet recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
Qingshan Li, bachelor, libing200865@126.com
Qingshan Li, bachelor
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Xiaoyan Lin, Doctor, xiaoyanlin@yahoo.com
Xiaoyan Lin, Doctor
- Not yet recruiting
Harbin Medical University Affiliated Tumor Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, Doctor, yanqiaozhang@126.com
Yanqiao Zhang, Doctor
- Not yet recruiting
Anhui Provincal Hospital
Hefei, Anhui, 230001
Yueyin Pan, Doctor, yueyinpan1965@126.com
Yueyin Pan, Doctor
- Not yet recruiting
Tongji Medical College of HUST
Wuhan, Hubei, 430040
Hong Qiu, Doctor, tjqiuhong@163.com
Hong Qiu, Doctor
- Not yet recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450003
Xiaobing Chen, Doctor, 2290773710@qq.com
Xiaobing Chen, Doctor
About this study
Official title: 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
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.
- Conditions
- Advanced Biliary Cancer
- Being tested
- TQB2450 Injection, Anlotinib hydrochloride, Oxaliplatin injection, Capecitabine tablets, Gemcitabine hydrochloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450 InjectionDrug
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Anlotinib hydrochlorideDrug
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).
Oxaliplatin injectionDrug
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Capecitabine tabletsDrug
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Gemcitabine hydrochloride injectionDrug
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.
| Study group | Role | What they receive |
|---|---|---|
| TQB2450+Anlotinib | Experimental | 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). Receives: Drug: TQB2450 Injection; Drug: Anlotinib hydrochloride |
| Chemotherapy | Active comparator | Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks. Receives: Drug: Oxaliplatin injection; Drug: Capecitabine tablets; Drug: Gemcitabine hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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.
Measured: up to 40 weeks
Secondary outcomes (7)
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 24 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 24 weeks
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 24 weeks
Duration of response（DOR）
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 24 weeks
Progression-free survival at 6 months
Percentage of participants whose PFS has achieved at least 6 months.
Measured: up to 6 months
Overall survival at 6 months
Percentage of participants whose OS has achieved at least 6 months.
Measured: up to 6 months
Overall survival at 12 months
Percentage of participants whose OS has achieved at least 12 months.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start4 Feb 2021
- Primary completion18 Mar 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809142
- Sponsor's protocol ID
- TQB2450-III-08
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04809142
- Acronym / sponsor ID
- TQB2450-III-08
- Conditions
- Advanced Biliary Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 18 Mar 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2450+Anlotinib | Experimental | Drug: TQB2450 Injection, Drug: Anlotinib hydrochlorideTQB2450 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). |
| Chemotherapy | Active comparator | Drug: Oxaliplatin injection, Drug: Capecitabine tablets, Drug: Gemcitabine hydrochloride injectionCapecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
- 2.18 years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.5.
- 3. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.
- 5.Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.
Key exclusion criteria (29 listed)
- 1. Tumor disease and medical history:
- <!-- -->
- <!-- -->
- 6. Pregnant or breastfeeding women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450 InjectionTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle. | Drug | TQB2450+Anlotinib |
| Anlotinib hydrochlorideAnlotinib 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). | Drug | TQB2450+Anlotinib |
| Oxaliplatin injectionOxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles; | Drug | Chemotherapy |
| Capecitabine tabletsCapecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles; | Drug | Chemotherapy |
| Gemcitabine hydrochloride injectionGemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles. | Drug | Chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: up to 40 weeks
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.
7 secondary outcomes
Progression free survival (PFS)
Time frame: up to 24 weeks
Overall response rate (ORR)
Time frame: up to 24 weeks
Disease control rate（DCR）
Time frame: up to 24 weeks
Duration of response（DOR）
Time frame: up to 24 weeks
Progression-free survival at 6 months
Time frame: up to 6 months
Overall survival at 6 months
Time frame: up to 6 months
Overall survival at 12 months
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2450 Injection, Anlotinib hydrochloride and Oxaliplatin injection in people with Advanced Biliary Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.