Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial.
Xiangrui Meng, Tao Wu, Yonggui Hong...
https://pubmed.ncbi.nlm.nih.gov/34998471Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID03736863
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-09-19
147
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating multiple drug combinations to treat advanced esophageal squamous cell carcinoma, focusing on patients who have experienced progression or intolerance to first-line chemotherapy or immunotherapy. The study aims to explore the safety and effectiveness of these treatments, especially for those who have developed resistance to immunotherapy, as current standard second-line treatments are limited. This phase II exploratory trial investigates different combinations to identify better therapy options for advanced esophageal cancer. The trial includes several treatment groups receiving combinations of drugs such as Apatinib with Camrelizumab or Adebrelimab, administered orally or by intravenous injection at specified doses and intervals. Participants are assigned to cohorts based on prior treatment history, with regimens designed for patients who have failed chemotherapy or immune checkpoint inhibitor therapies. The study drugs are given on schedules ranging from every two to three weeks, and the trial does not use randomization or blinding. Participants will undergo regular evaluations including imaging scans to measure tumor response, blood tests to assess organ function, and collection of tissue samples for biomarker analysis. Researchers will monitor objective response rates as the primary outcome over one year, along with secondary outcomes like disease control, survival rates, time to response, and safety over up to two years. The study requires participants to have good performance status and adequate organ function, with follow-up visits and safety assessments conducted throughout the study duration.
CONDITIONS
Brief Title
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years, male or female
- Histologically or cytologically confirmed advanced esophageal squamous cell carcinoma with local recurrence or distant metastases
- Progressed or intolerant to first-line chemotherapy or immunotherapy
- Best overall response to first-line immunotherapy is complete response, partial response, or stable disease with progression-free survival of at least 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- Willing to provide tissue samples for biomarker analysis
- ECOG performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate major organ function based on blood and biochemical tests
- Left ventricular ejection fraction at or above the lower limit of normal (50%)
- Women of childbearing potential and men agree to use contraception during the study and for 6 months after
- Able and willing to provide informed consent and comply with study procedures
You will not qualify if you...
- Active or history of autoimmune diseases or certain immune-related conditions
- Previous radiation therapy with unresolved radiation pneumonia or toxicities requiring corticosteroids
- Current use of immunosuppressants or systemic hormone therapy above specified doses
- Active bleeding in primary esophageal lesions
- Prior use of the same drugs studied (except immune checkpoint inhibitors)
- Conditions affecting oral drug intake like swallowing difficulties or gastrointestinal issues
- Brain metastases within the past 3 months
- Severe or uncontrolled diseases including blood pressure, heart conditions, infections, liver diseases, or kidney impairment
- Unhealed wounds or bone fractures
- Significant bleeding events or bleeding tendencies within 4 weeks before recruitment
- Recent thrombotic events within 6 months
- Tumor invasion of major blood vessels with risk of fatal hemorrhage
- Pregnancy or breastfeeding
- History of other malignancies within 5 years except certain cured cancers
- History of psychotropic drug abuse or mental disorders
- Participation in other drug clinical trials within 4 weeks
- Conditions judged by investigator to impair safety or study completion
- Other reasons deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive one of several drug combinations involving Apatinib and immunotherapy agents via oral and intravenous routes to treat advanced esophageal squamous cell carcinoma.
Visits every 2 or 3 weeks depending on the drug combination
Follow-up
Duration - Up to 2 years
Participants are monitored for safety and long-term treatment outcomes after completing the treatment phase.
Periodic visits for safety and survival assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
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Research Team
F
Feng Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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