Actively Recruiting
An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy
Led by Jiangxi Provincial Cancer Hospital · Updated on 2022-12-16
30
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the combination of Anlotinib Hydrochloride Capsules and TQB2450 Injection as a postoperative adjuvant therapy for patients with esophageal squamous cell carcinoma (ESCC). This Phase II, open-label, single-arm study aims to assess the efficacy and safety of this combination treatment, focusing primarily on disease-free survival (DFS). The study also looks at one- and three-year DFS and overall survival rates, along with safety outcomes classified by adverse event severity. Participants will receive treatment in 21-day cycles, taking Anlotinib orally at 12 mg daily for the first 14 days, along with a single intravenous dose of 1200 mg TQB2450 on day one of each cycle. If participants experience side effects from Anlotinib, the dose may be reduced to 10 mg or 8 mg. The study treatment continues as determined by the researchers. During the study, participants will be closely monitored through laboratory tests and imaging to detect any cancer recurrence or progression. Researchers will track disease-free survival from the start of treatment up to 96 months, along with overall survival rates at one and three years. Safety will be evaluated by recording and categorizing adverse events. Participants are expected to follow up regularly and comply with study procedures throughout the treatment and observation period.
CONDITIONS
Brief Title
Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 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
- Pathological diagnosis of esophageal squamous cell carcinoma classified as T1-2N1-3M0 or T3-4NanyM0
- Underwent radical (R0) resection of squamous cell carcinoma with no recurrence on imaging within 6-12 weeks after surgery
- Laboratory tests meeting: neutrophils count ≥ 1.5 x 10^9/L, platelets count ≥ 75 x 10^9/L, hemoglobin ≥ 90 g/L, WBC ≥ 3 x 10^9/L
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT and AST ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN
- APTT, INR, PT ≤ 1.5 x ULN
- Thyroid-stimulating hormone (TSH) ≤ ULN
- Myocardial enzymes within normal range
- Left ventricular ejection fraction (LVEF) ≥ 50%
You will not qualify if you...
- Received other antitumor adjuvant therapy after surgery
- Concurrent malignancy except cured basal cell carcinoma of the skin
- Diagnosed with cervical esophageal carcinoma
- Prior targeted therapy (anti-VEGF/VEGFR) or immunotherapy (anti-PD-1/PD-L1/CTLA-4)
- Allergy to monoclonal antibodies
- History of immunodeficiency or active autoimmune disease
- Use of immunosuppressants or systemic/absorbable steroids >10 mg/day prednisone or equivalent within 2 weeks before treatment
- Multiple factors affecting oral drug administration
- Uncontrolled pleural, pericardial effusion or ascites needing repeated drainage
- Bleeding tendency or recent severe bleeding events
- Active digestive diseases or tumors with bleeding risk
- Active or untreated central nervous system metastases
- Poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Myocardial infarction, ischemia, arrhythmias with poor control, or cardiac insufficiency grade II
- Severe infection (≥ grade 2)
- HIV positive
- Proteinuria ≥ 2+ or urinary protein >1.0 g/24h
- Vaccination with prophylactic or attenuated vaccine within 4 weeks before treatment
- Other factors deemed by investigators to endanger patient or prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive Anlotinib Hydrochloride capsules orally once daily for 2 weeks followed by 1 week off, combined with a TQB2450 injection intravenously on Day 1 of each 21-day cycle.
1 visit per 21-day cycle (in-person)
Trial Site Locations
Total: 1 location
1
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
C
Changying Guo, PhD
W
Weimin Mao, PhD
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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