The current management and biomarkers of immunotherapy in advanced gastric cancer.
Xiaojing Chang, Xiaohui Ge, Yufeng Zhang...
https://pubmed.ncbi.nlm.nih.gov/35623069Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04278222
Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Treatment in Frail Patients with Advanced Gastric Cancer (ECOG 2)
Led by Shanghai Changzheng Hospital · Updated on 2024-07-10
24
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining two drugs, Anlotinib and Toripalimab, as a first treatment option for patients with advanced gastric cancer who have an ECOG performance status of 2. This is a Phase II trial designed to assess this new approach in a group of frail patients with this type of cancer. Anlotinib is a new oral drug targeting multiple growth factor receptors, while Toripalimab is an antibody that may help the immune system fight cancer cells. Participants will receive Anlotinib orally at a dose of 12 mg daily for 14 days out of every 21-day cycle, along with Toripalimab given intravenously at 240 mg on day 1 of each 21-day cycle. This treatment combination will be given as the first-line therapy for their advanced gastric cancer. The trial is a single-arm, open-label study conducted at one center. Throughout the study, researchers will monitor changes in tumor size using standard criteria every eight weeks to evaluate response. They will also track progression-free survival, overall survival, disease control rate, depth of tumor response, and any side effects. Safety assessments will occur regularly, with an average four-week monitoring period for adverse events. Participants' involvement will continue until disease progression, unacceptable toxicity, or withdrawal from the study.
CONDITIONS
Brief Title
Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV gastric cancer
- No prior systemic anti-cancer treatment with relapse or metastasis more than 12 months after adjuvant chemotherapy
- At least one measurable tumor lesion
- ECOG performance status of 2
- Adequate organ function including hemoglobin ≥ 90g/L, ANC ≥ 1.5 × 10^9/L, platelets ≥ 80 × 10^9/L, bilirubin and liver enzymes within specified limits, serum creatinine ≤ 1.5 × ULN
- Patient provides written informed consent
- Estimated life expectancy greater than 3 months
You will not qualify if you...
- HER2 positive status (IHC 3+ or IHC 2+ with FISH positive)
- dMMR/MSI-H status
- History of myocardial infarction, unstable angina, or severe heart failure (NYHA III or IV)
- Prior treatment with Anlotinib or immune checkpoint inhibitors
- Known or suspected brain metastases, autoimmune disease, or organ transplantation
- Severe wounds or surgery within 4 weeks before enrollment
- Use of glucocorticoids (>10 mg prednisone) or immunosuppressants
- History of second malignancy within past 5 years except certain skin or cervical cancers treated curatively
- Pregnant or breastfeeding
- Absent or restricted legal capacity
- Significant concurrent disease that prevents participation as judged 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 - Repeated 3-week cycles until disease progression or discontinuation
Participants receive Anlotinib orally daily for 14 days and Toripalimab by intravenous infusion on Day 1 of each 3-week cycle as first-line treatment for advanced gastric cancer.
Visits every 3 weeks for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China
Actively Recruiting
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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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