Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04278222

Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)

Led by Shanghai Changzheng Hospital · Updated on 2024-07-10

24

Participants Needed

1

Research Sites

255 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Histologically confirmed, UICC stage IV gastric cancer
  • No prior systemic anti-cancer treatment unless relapse or metastases occurred more than 12 months after adjuvant chemotherapy
  • At least one measurable lesion
  • Radiotherapy within 3 weeks before recruitment allowed only if lesion treated is excluded from tumor response evaluation
  • ECOG performance status 2
  • Adequate organ function: Hemoglobin 90 g/L, ANC 1.5 x 10^9/L, Platelets 80 x 10^9/L, Bilirubin <1.5 x ULN (or <3 x ULN if liver metastases), ALT and AST <2.5 x ULN (or <5 x ULN if liver metastases), Serum creatinine 1.5 x ULN
  • Written informed consent obtained
  • Estimated life expectancy greater than 3 months
Not Eligible

You will not qualify if you...

  • HER2 positive gastric cancer (IHC 3+ or IHC 2+ with FISH positive)
  • Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H)
  • History of myocardial infarction, unstable angina, or severe heart failure (NYHA Grade III or IV)
  • Prior treatment with Anlotinib or other immune checkpoint inhibitors
  • Known or suspected brain metastases, autoimmune disease, or organ transplantation
  • Severe wounds or surgery within 4 weeks before recruitment
  • Use of glucocorticoids (>10mg prednisone) or immunosuppressive agents
  • History of second malignancy within past 5 years except treated basal or squamous cell carcinoma or cervical carcinoma in situ
  • Pregnancy or breastfeeding
  • Absent or restricted legal capacity
  • Any significant concomitant disease that would prevent participation according to investigator's judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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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