Actively Recruiting
Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-03-04
105
Participants Needed
30
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in subjects with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same patient population.
CONDITIONS
Official Title
Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate and sign informed consent with good compliance
- Age between 18 and 75 years old (inclusive)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival greater than 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Laboratory values within specified limits: hemoglobin ≥ 90 g/L; neutrophils ≥ 1.5×10⁹/L; platelets ≥ 90×10⁹/L; total bilirubin ≤ 1.5× upper limit of normal (ULN); ALT/AST ≤ 2.5× ULN (≤ 5× ULN if liver metastases present); serum creatinine ≤ 1.3× ULN or creatinine clearance rate ≥ 50 mL/min
- Histologically or cytologically confirmed recurrent or metastatic esophageal cancer
- Failure or intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic esophageal carcinoma
- Willingness to provide archived or fresh tumor tissue for biomarker analysis
- For females of childbearing potential: negative pregnancy test within 7 days before enrollment and agreement to use effective contraception during and for 6 months after the study
- Males agree to use effective contraception during and for 6 months after the study
You will not qualify if you...
- Current or history of other malignancies
- Conditions compromising venous access for drug administration or blood sampling
- Unresolved treatment-related adverse reactions greater than Grade 1 per CTCAE v5.0
- Major surgery or significant injury within 4 weeks prior to first dose, scheduled major surgery during treatment, or non-healing wounds, ulcers, or bone fractures at screening
- Bleeding or hemorrhagic events Grade 3 or higher within 4 weeks before first dose
- History of thromboembolic events within 6 months
- Poorly controlled active viral hepatitis
- Active syphilis infection requiring antimicrobial therapy
- Pulmonary conditions including active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis requiring treatment, symptomatic active pneumonia, or history of interstitial lung disease requiring therapy
- History of substance abuse or psychiatric disorders
- History of allogeneic bone marrow or solid organ transplantation
- History of hepatic encephalopathy
- Major cardiovascular diseases
- Active or uncontrolled severe infections
- Renal failure requiring dialysis
- History of immunodeficiency
- Poorly controlled autoimmune diseases or epilepsy requiring treatment
- Poorly controlled diabetes
- Recent anticancer treatment within 3 weeks or within 5 half-lives
- Recent use of NMPA-approved anticancer traditional Chinese medicine within 1 week
- Tumor-related conditions: tumor encasement of major vessels with high bleeding risk, uncontrolled effusions requiring repeated drainage, spinal cord compression, leptomeningeal metastasis, symptomatic brain metastases without at least 4 weeks control
- Known hypersensitivity to study drug or excipients
- Prior treatment with topoisomerase I inhibitor-based ADCs or irinotecan chemotherapy
- Participation in anticancer clinical trials within 4 weeks
- Investigator-assessed safety or compliance concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230061
Not Yet Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
4
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
5
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515000
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
7
Guizhou Provincial People's Hospital
Guangxi, Guizhou, China, 550002
Not Yet Recruiting
8
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563006
Not Yet Recruiting
9
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
10
Anyang Cancer Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
11
The Second People's Hosital of Jiaozuo
Jiaozuo, Henan, China, 454001
Not Yet Recruiting
12
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China, 471000
Not Yet Recruiting
13
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China, 450000
Actively Recruiting
14
Zhengzhou Central Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
15
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Not Yet Recruiting
16
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
17
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China, 210019
Not Yet Recruiting
18
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225009
Not Yet Recruiting
19
The first hospital of jilin university
Changchun, Jilin, China, 130012
Not Yet Recruiting
20
Jilin Cancer Hospital
Changchun, Jilin, China, 130021
Not Yet Recruiting
21
Linyi cancer Hospital
Liyi, Shandong, China, 276034
Not Yet Recruiting
22
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
23
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
24
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China, 710000
Not Yet Recruiting
25
Sichuan cancer hosipital
Chengdu, Sichuan, China, 610040
Not Yet Recruiting
26
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
27
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 64600
Not Yet Recruiting
28
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
29
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
30
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Not Yet Recruiting
Research Team
F
Feng Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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