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A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03631459
Enrollment
100000
Registered
2018-08-15
Start date
2018-08-20
Completion date
2020-07-20
Last updated
2018-08-21

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

Conditions

Cancer Cachexia

Keywords

Kanglaita Injection/Capsule, Cancer cachexia, Real-world evidences, Overall survival

Brief summary

A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia

Detailed description

This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.

Interventions

DRUGKanglaite Injection/Capsules

Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles

Sponsors

NanJing PLA 81 Hospital
CollaboratorOTHER
LinkDoc Technology (Beijing) Co. Ltd.
CollaboratorINDUSTRY
Zhejiang Kanglaite Pharmaceutical Co.Ltd
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Overall survival2018 - 2020Overall survival

Secondary

MeasureTime frameDescription
Lean body mass2018 - 2020Lean body mass
Body weight2018 - 2020Body weight
Grade of cachexia2018 - 2020Grade of cachexia
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C302018 - 2020European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30: 30 items, including functioning, symptoms, and overall health. min: 0, max: 100. The higher values indicate higher level of functioning and quality of life
Karnofsky performance status2018 - 2020Karnofsky performance status
Synergistic antitumor effect: Overall response rate2018 - 2020Synergistic antitumor effect: Overall response rate
Synergistic antitumor effect: Disease control rate2018 - 2020Synergistic antitumor effect: Disease control rate
Patient-generated subjective global assessment (PG-SGA)2018 - 2020Patient-generated subjective global assessment (PG-SGA)
Numeric rating scale for pain2018 - 2020Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.
Numeric rating scale for appetite2018 - 2020Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite

Other

MeasureTime frameDescription
Adverse events2018 - 2020Adverse events
Serious adverse event2018 - 2020Serious adverse event

Countries

China

Contacts

Primary ContactShukui Qin, MD
qinsk@csco.org.cn0086-025-84453932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026