Actively Recruiting
Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
Led by Jiangxi Provincial Cancer Hospital · Updated on 2022-12-16
30
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
J
Jiangxi Provincial Cancer Hospital
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).
CONDITIONS
Official Title
Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered to join the study and signed informed consent with good compliance and follow-up
- 18 years old or older
- ECOG performance status of 0-1
- Diagnosed with esophageal squamous cell carcinoma staged T1-2N1-3M0 or T3-4NanyM0
- Had radical (R0) surgical removal of the tumor with no recurrence seen on imaging within 6-12 weeks after surgery
- Laboratory values meeting neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 90 g/L, white blood cells ≥ 3 x 10^9/L
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN), ALT and AST ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Coagulation tests (APTT, INR, PT) ≤ 1.5 times ULN
- Thyroid stimulating hormone (TSH) within normal limits
- Normal myocardial enzyme levels
- Left ventricular ejection fraction (LVEF) ≥ 50%
You will not qualify if you...
- Received other antitumor adjuvant therapy after surgery
- Have concurrent cancers except cured basal cell carcinoma of the skin
- Diagnosed with cervical esophageal carcinoma
- Previously treated with targeted therapy (anti-VEGF/VEGFR) or immunotherapy (anti-PD-1/PD-L1/CTLA-4)
- Allergic to monoclonal antibodies
- History of immunodeficiency or active autoimmune disease
- Taking immunosuppressants or systemic/absorbable local hormone therapy over 10 mg prednisone or equivalent within 2 weeks before treatment
- Conditions affecting ability to take oral medication
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Bleeding tendency or recent grade 3 bleeding events within 4 weeks before treatment
- Active digestive diseases or bleeding tumors risking gastrointestinal bleeding or perforation
- Active or untreated brain metastases
- Poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Recent serious heart conditions including myocardial infarction, ischemia, arrhythmias, or heart failure grade II
- Active or uncontrolled serious infections
- Positive HIV test
- Significant proteinuria (≥ 2+ or 24-hour urine protein >1.0 g)
- Vaccinated with live or attenuated vaccine within 4 weeks before treatment
- Any other factors judged by investigators to endanger participant or prevent study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
C
Changying Guo, PhD
CONTACT
W
Weimin Mao, PhD
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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