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Efficiency and safety of anlotinib hydrochloride plus SOX as first line therapy for advanced gastric cancer

Efficiency and safety of anlotinib hydrochloride plus SOX as first line therapy for advanced gastric cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020047
Enrollment
Unknown
Registered
2018-12-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Group 1:anlotinib, oxaliplation, S1
Group 2:oxaliplation, S1

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) informed consent; (2) aged 18-75 years old; (3) histology confirmed advanced gastric adenocarnoma (including GEJ),with Measurable tumors (according to RECIST 1.1); (4) ECOG:0-1, expected survival 3 months or more; (5) with adequate organ function: HB=90g/L,ANC=1.5×10^9/L,PLT=80×10^9/L; TBIL=1.5*ULN, ALT and AST=2.5*ULN (=5*ULN in case of liver metastasis), Cr=1.5*ULN or CCr=60ml/min; LVEF=50%.

Exclusion criteria

Exclusion criteria: (1) took anlotinib before; (2) took other VEGF-TKI before; (3) with other primary malignant tumor except for cured cervical in situ cancer, non-melonoma skin cancer; (4) received other systemic therapy for metastatic disease, including cytotoxical agents, cell signaling inhibitors, immune therapies,or local radiation; (5) with potential bleeding disease; (6) uncontrolled hypertension,severe heart disease, active infection, cihorrosis,active hepatitis, uncontrolled diabetes; (7) Urine protein ++ or more,or >1.0 g/24h; (8) enrolled in other clinical trials in recent 4 weeks; (9) other conditions unfit for study, judged by investigator.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;OS;QoL;side effect;

Countries

China

Contacts

Public ContactJiqing HAO

The First Affiliated Hospital of Anhui Medical University

ayfy_hjq@163.com+86 0551-62923615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026