Actively Recruiting
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-11-07
80
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.
CONDITIONS
Official Title
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 to 75 years, male or female
- ECOG performance status score 0-1
- Histologically or cytologically confirmed gastric or gastroesophageal junction carcinoma
- Treated with radical resection (D2, R0 or R1) of gastric cancer
- Pathological stage III (8th AJCC TNM)
- Estimated lifetime greater than 6 months
- Main organs functioning well with blood tests meeting specified criteria within 14 days before enrollment
- No obvious clinical symptoms of heart disease
- Disease-free status confirmed by physical exam and imaging with no evidence of recurrence within 28 days prior to enrollment
- Females of childbearing potential must have negative pregnancy test within 7 days of randomization and agree to use effective birth control during study and specified follow-up periods
- Willing to participate and sign informed consent
- Allowed one cycle of XELOX chemotherapy after ctDNA sampling due to NGS analysis time
You will not qualify if you...
- Participation in other drug clinical trials within four weeks
- Conditions affecting oral medication such as inability to swallow or chronic diarrhea
- History of bleeding events grade 3 or higher within 4 weeks before screening
- Known or suspected central nervous system metastasis
- Uncontrolled hypertension or recent heart conditions including unstable angina or recent myocardial infarction
- Significant arrhythmias or cardiac insufficiency (NYHA Class II or higher)
- Conditions affecting oral drug absorption
- Long-term unhealed wounds or fractures
- Tumors invading important blood vessels with high bleeding risk
- Abnormal coagulation or bleeding tendencies
- Recent arteriovenous thrombotic events within 6 months
- Urine protein levels above specified limits
- Prior use of immune targeted therapy drugs
- History of immunodeficiency or organ transplantation
- Active infections requiring corticosteroids or severe chronic autoimmune diseases
- Hypersensitivity to monoclonal antibodies
- History of psychotropic substance abuse or mental disorders
- Pleural or peritoneal effusion requiring intervention
- Non-compliance with medical advice or insufficient data for evaluation
- Concomitant diseases that pose safety concerns or affect study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Y
Yongqian Shu, PhD
CONTACT
X
Xiaofeng Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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