Skip to content

A Randomized, Controlled, Multicenter Clinical Trial of Kangai Injection in Combination with Chemotherapy XELOX in Treatment of Colorectal 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-13003886
Enrollment
Unknown
Registered
2013-10-09
Start date
2013-10-25
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

colorectal cancer

Interventions

Experiment group:Kangai injection 60ml ivgtt D1-14 Q21d, combined with chemotherapy: Eloxatin 130mg/m2 2h ivgtt d1, Xeloda 1000mg/m2 bid po d1-14 Q21d
Control group:Chemotherapy: Eloxatin 130mg/m2 2h ivgtt d1, Xeloda 1000mg/m2 bid po d1-14 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. Postoperative or inoperable Colorectal Cancer patients, at stage II, III, IV, need chemotherapy XELOX; 2. ECOG score 0-1; 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 Colorectal Cancerat 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; 2. psychotic patient; 3. Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; 4. using other experimental drugs or paticipate in other clinical trials at the same time; 5. patients allergic to the investigational product; 6. patients undergoing radiotherapy.

Design outcomes

Primary

MeasureTime frame
Adverse Reactions;

Secondary

MeasureTime frame
Clinical Symptoms,Quality of Life,KPS Score Immunologic Function, Tumor Marker, Passing Rate of Chemotherapy;

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