Skip to content

A Randomized, Controlled, Multicenter Clinical Trial of Kangai Injection in Combination with Chemotherapy OFL in Treatment of Gastric Cancer

Post-marketing Clinical Research on Kangai Injection in Treatment of Malignant Neoplasm

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003885
Enrollment
Unknown
Registered
2013-10-09
Start date
2013-04-23
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

gastric cancer

Interventions

Experiment group:Kangai injection 60ml ivgtt D1-10 Q21d, combined with Chemotherapy OFL: L-OHP 130mg/m2 ivgtt d1, CF 200mg ivgtt d1-5, 5-FU 500 mg/m2 ivgtt d1-5, Q21d
Control group:Chemotherapy OFL: L-OHP 130mg/m2 ivgtt d1, CF 200mg ivgtt d1-5, 5-FU 500 mg/m2 ivgtt d1-5, Q21d

Sponsors

Guang’anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of gastric cancer according to pathology or cytology; (2) KPS>=60?; (3) Aged from 18 to 75 years old; (4) ANC>1.5*10^9/L, PLT>100*10^9/L, Hb>9.0g/dl, BIL at normal level or < 1.5 x ULN, AST (SGOT)ALT (SGPT) < 2.5 x ULN; SCr< 1.5 x ULN; (5) Signed informed consent, with good compliance.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women,psychotic patient; (2) Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; (3) using other experimental drugs or paticipate in other clinical trials at the same time; (4) patients allergic to the investigational product.

Design outcomes

Secondary

MeasureTime frame
Quality of Life, progression-free survival (PFS), Tumor Marker, Weight;

Primary

MeasureTime frame
Adverse Reaction;

Countries

China

Contacts

Public ContactHongsheng Lin

Guang’anmen Hospital affiliatied to China Academy of Chinese Medical Sciences

drlinhongsheng@163.com+86 10 88001500

Outcome results

None listed

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