Actively Recruiting
Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-04-06
177
Participants Needed
29
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to demonstrate that in subjects with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, TQ-B3234 capsules significantly improve the objective response rate at Week 24 compared to placebo.
CONDITIONS
Official Title
Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Voluntary participation with signed informed consent and good compliance
- Diagnosis of symptomatic, non-resectable neurofibromatosis type 1-associated plexiform neurofibroma requiring systemic therapy
- At least one measurable lesion 3 cm or larger
- Stable use of chronic neuropathic pain medications within 28 days before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Laboratory test results meeting protocol requirements
- Women of childbearing potential must use effective contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment
- Men must use effective contraception during the study and for 6 months after completion
You will not qualify if you...
- Confirmed or suspected malignant glioma or malignant peripheral nerve sheath tumor (excluding low-grade glioma and optic nerve glioma not requiring systemic therapy or radiotherapy)
- History or current other malignancies within 5 years before first dose
- Conditions affecting oral drug absorption such as dysphagia, chronic diarrhea, intestinal obstruction, or major bowel resection
- Unresolved adverse reactions from previous anti-tumor therapy above grade 1 (except specified exceptions)
- Major surgery, significant injury, or planned major surgery within 4 weeks prior to first dose; presence of unhealed wounds or fractures
- History of arterial or venous thrombotic events or severe thromboembolic events within 6 months before first dose
- Active viral hepatitis poorly controlled
- Active syphilis needing treatment
- Active tuberculosis, pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or symptomatic pneumonia
- History of substance abuse or uncontrolled psychiatric disorders
- Planned or previous allogeneic bone marrow or solid organ transplantation
- History of hepatic encephalopathy
- History or current retinal vein occlusion, retinal pigment epithelial detachment, central serous retinopathy, glaucoma, or other significant eye abnormalities
- Inability to undergo MRI or presence of MRI contraindications
- Major cardiovascular disease
- Active or uncontrolled severe infection
- Renal failure requiring dialysis
- History of immunodeficiency including HIV or congenital/acquired immunodeficiency
- History of epilepsy
- Tumor-related symptoms and treatment
- Known hypersensitivity to study drug components
- Participation in other plexiform neurofibroma clinical trial drugs within 4 weeks prior to first dose
- Pregnant or breastfeeding participants
- Any other condition that poses a serious safety risk or interferes with study completion according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
3
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
4
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
5
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
Not Yet Recruiting
6
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
7
The First Affiliated Hospital of Fujan Medical University
Fuzhou, Fujian, China, 350004
Not Yet Recruiting
8
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
9
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
10
Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital / Guangdong Center for the Prevention and Control of Sexually Transmitted Diseases and Leprosy
Guangzhou, Guangdong, China, 510091
Not Yet Recruiting
11
Guangxi Medical University Cancer Hospital （ Guangxi Cancer InstituteGuangxi Cancer Hospital & Medical University Oncology School & Cancer Center）
Nanning, Guangxi, China, 530021
Not Yet Recruiting
12
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
13
The second hospital of Hebei medical university
Shijiazhuang, Hebei, China, 05000
Not Yet Recruiting
14
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
15
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
16
Renmin Hospital of Wuhan University(Hubei General Hospital)
Wuhan, Hubei, China, 42000
Not Yet Recruiting
17
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Not Yet Recruiting
18
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
19
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110801
Not Yet Recruiting
20
Xijing hospital
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
21
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
22
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
23
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Not Yet Recruiting
24
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
25
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
26
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
27
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
28
The First Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan, China, 650000
Not Yet Recruiting
29
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
Q
Qingfeng Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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