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A Randomized, Controlled, Multicenter Clinical Trial of Kangai Injection in Treatment of Patients with Advanced Digestive System Neoplasm

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-13003873
Enrollment
Unknown
Registered
2013-10-10
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

Digestive System Neoplasm

Interventions

Experiment group:Kangai injection 40ml 2ivgtt D1-21, combined with the best supportive treatment

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 IV stage digestive system neoplasm according to pathology or cytology; 2. haven't take radiotherapy or chemotherapy, or have finished radiotherapy or chemotherapy treatment for 1 month; 3. KPS score>50; 4. Aged from 18 to 75; 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 antitumor methods or drugs, such as radiotherapytargeted drugsor paticipate in other clinical trials at the same time; 4. patients allergic to the investigational product.

Design outcomes

Primary

MeasureTime frame
Clinical Symptoms;Quality of Life;QLQ-C30;Adverse Reaction;

Secondary

MeasureTime frame
PFS;RR;DCR;Tumor Marker;Weight;OS;

Countries

China

Contacts

Public ContactHongsheng Lin

Guang'anmen Hospital, 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