NCT04278222 Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
| NCT ID | NCT04278222 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2020-02-10 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2020-02-10 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 × ULN, ALT and AST \<5 × ULN; Serum Cr ≤ 1.5 × ULN; * Patient's written declaration of consent obtained; * Estimated life expectancy \> 3 months; Exclusion Criteria: * 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 situ, if these were treated curatively. * 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
Frequently Asked Questions
Who can join the NCT04278222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04278222 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04278222 currently recruiting?
Yes, NCT04278222 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Changzheng Hospital to inquire about joining.
Where is the NCT04278222 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04278222 clinical trial?
NCT04278222 is sponsored by Shanghai Changzheng Hospital. The trial plans to enroll 24 participants.
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