Actively Recruiting
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-04-08
102
Participants Needed
43
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
CONDITIONS
Official Title
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years with an ECOG performance status of 0 or 1
- Confirmed HER2-positive biliary tract cancer by central lab testing (IHC 3+ or IHC 2+ with ISH positive)
- Adequate function of major organs
- Advanced biliary tract cancer confirmed by histology or cytology
- Non-operable locally advanced, recurrent or metastatic disease with at least one measurable lesion
- Failure of 1-2 prior lines of systemic therapy
- Women of reproductive age and men agree to use effective contraception during and for 6 months after the study
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- History of other malignant tumors within 3 years before first medication
- Unresolved toxic effects higher than grade 1 from previous treatment
- Major surgery, significant injury, or unhealed wounds/fractures within 4 weeks prior to initial medication
- Bleeding events of grade 3 or higher within 4 weeks before first dose or recent thrombotic events within 6 months
- Active viral hepatitis poorly controlled
- History of active tuberculosis, various pneumonias, or pulmonary fibrosis requiring treatment
- History of psychotropic drug abuse or mental disorders
- Previous or planned bone marrow or solid organ transplant
- History of hepatic encephalopathy
- Recent use of certain antiplatelet drugs or aspirin exceeding allowed doses
- Severe or uncontrolled diseases
- Recent chemotherapy, immunotherapy, radiation, or targeted drugs within specified washout periods
- Use of Chinese patent anti-tumor drugs within 2 weeks before first dose
- Tumor invasion of important blood vessels or high risk of fatal bleeding
- Uncontrolled pleural, pericardial effusion, or moderate to severe ascites requiring drainage
- Significant biliary obstruction except controlled cases after stenting or drainage
- Known spinal cord compression, cancerous meningitis, or recent brain metastases symptoms
- Allergy to study drug components
- Prior anti-HER2 therapy in the second stage of the study
- Need for immunosuppressive therapy within 7 days prior to initial administration
- Participation in other anti-tumor clinical trials within 4 weeks before first medication
- Any condition that endangers safety or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
Fuyang Cancer Hospital
Fuyang, Anhui, China, 236010
Not Yet Recruiting
2
Anhui Second People's Hospital
Hefei, Anhui, China, 230012
Not Yet Recruiting
3
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
4
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100089
Not Yet Recruiting
6
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, China, 100089
Not Yet Recruiting
7
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
8
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
9
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
10
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510062
Not Yet Recruiting
11
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Not Yet Recruiting
12
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
13
Guangxi University Affiliated Hospital
Nanning, Guangxi, China, 530220
Not Yet Recruiting
14
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
15
Tangshan People's Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
16
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
17
AnYang Tumor Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
18
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China, 471000
Not Yet Recruiting
19
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
20
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Not Yet Recruiting
21
Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Not Yet Recruiting
22
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China, 430071
Not Yet Recruiting
23
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Not Yet Recruiting
24
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Not Yet Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
26
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
27
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
28
Dongtai People'S Hospital
Yancheng, Jiangsu, China, 224200
Not Yet Recruiting
29
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
30
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
31
Chifeng City Hospital
Chifeng, Neimengu, China, 024000
Not Yet Recruiting
32
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
33
Cancer Hospital of Shan dong First Medical University
Jinan, Shandong, China, 250000
Not Yet Recruiting
34
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Not Yet Recruiting
35
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
36
The Third Affiliated Hospital of PLA Navy Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
37
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
38
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
39
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
40
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
41
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
42
Zhejiang University Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
43
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China, 314000
Not Yet Recruiting
Research Team
F
Feng Shen, Doctor
CONTACT
J
Jun Zhou, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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