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

Advanced Biliary Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809142
• Other study ID #: TQB2450-III-08
• Status: Recruiting
• Phase: Phase 3
• Start date: February 4, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 392
• Est. completion date: February 1, 2023
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 1. Tumor disease and medical history:

1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;

2. Has other malignant tumors within 5 years;

3. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;

4. Severe bone damage caused by tumor bone metastasis;

5. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;

6. Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved; 2. Previous anti-tumor therapy:

1. Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;

2. Have received anti-tumor therapy within 4 weeks before the first administration;

3. Unalleviated toxicity = grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:

1. Active hepatitis B or C;

2. Kidney abnormalities;

3. Abnormal thyroid function;

4. Cardiovascular abnormalities;

5. Gastrointestinal abnormalities;

6. History of immunodeficiency;

7. Has risk of bleeding;

8. Uncontrollable active bacterial, fungal or viral infections;

9. Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;

10. Allergies to the ingredients of the study drug;

11. Have a history of neurological or psychiatric disorders

12. 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;

13. Have a history of pituitary or adrenal dysfunction

14. Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;

15. Long-term unhealed wound or fracture;

16. 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.

Related Conditions & MeSH terms

• Advanced Biliary Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• TQB2450 Injection
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
• Anlotinib hydrochloride
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 injection
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
• Capecitabine tablets
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
• Gemcitabine hydrochloride injection
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chao-Yang Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Beijing Youan Hospital,Captical Medical University	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The First Peoples Hospital of Changzhou	Changzhou	Jiangsu
China	Affiliated Hospital of Chengde Medical University	Chengde	Hebei
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Harbin Medical University Affiliated Tumor Hospital	Harbin	Heilongjiang
China	Anhui Provincal Hospital	Hefei	Anhui
China	Tongji Medical College of HUST	Wuhan	Hubei
China	Henan Tumor Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 40 weeks
Secondary	Progression free survival (PFS)	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 24 weeks
Secondary	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 24 weeks
Secondary	Disease control rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 24 weeks
Secondary	Duration of response(DOR)	The time when the participants first achieved complete or partial remission to disease progression.	up to 24 weeks
Secondary	Progression-free survival at 6 months	Percentage of participants whose PFS has achieved at least 6 months.	up to 6 months
Secondary	Overall survival at 6 months	Percentage of participants whose OS has achieved at least 6 months.	up to 6 months
Secondary	Overall survival at 12 months	Percentage of participants whose OS has achieved at least 12 months.	up to 12 months