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New treatment option for Gastric Cancer
Official title Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
ClinicalTrials.gov ID: NCT04278222
What this study is testing
What is Anlotinib Plus Toripalimab?
Anlotinib Plus Toripalimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed, UICC stage IV gastric cancer;
- no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- at least one measurable lesion;
- received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using...
- ECOG performance status 2;
You likely can't join if
- harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
- dMMR/MSI-H;
- Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
- have received anlotinib or other immune checkpoint inhibitor ;
- with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
- severe wounds or surgery 4 weeks before recruitment;
See the full eligibility criteria
- Histologically confirmed, UICC stage IV gastric cancer;
- no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- at least one measurable lesion;
- received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
- ECOG performance status 2;
- the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN), ALT and AST \<2.5 × ULN and if liver metastases, BIL \< 3 ×...
- Patient's written declaration of consent obtained;
- Estimated life expectancy \> 3 months;
- harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
- dMMR/MSI-H;
- Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
- have received anlotinib or other immune checkpoint inhibitor ;
- with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
- severe wounds or surgery 4 weeks before recruitment;
- received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
- History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in...
- pregnancy or breast feeding;
- absent or restricted legal capacity;
- a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.