Health TrialsbyHealthPanel

Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer

ConditionAdvanced Colorectal Carcinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

About this trial

To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Combined with other malignant primary tumors;

Immunohistochemistry/polymerase chain reaction/second-generation sequencing results suggest MSI-H/dMMR patients;

Patients with recurrence and metastasis within 6 months after radical tumor surgery;

Patients who have previously or are undergoing cancer immunotherapy ; Patients undergoing radiation therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • first-line scheme+compound kushen injection

    Drug

    FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab+compound kushen injection Compound Kushen injection: intravenous infusion, 20ml at a time, diluted with 200ml sodium chloride injection, once a day, each cycle of chemotherapy should reach the cumulative dose of 200ml.

  • palliative care group first-line scheme

    Drug

    FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: first-line scheme + compound kushen injectionExperimental treatment 1 intervention
Group B: first-line schemeOther 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression Free Survival

Time frame
The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months

Secondary outcomes

1

OS

Overall survival

Time frame
The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
2

1-year survival rate

The probability of patients surviving more than 1 year after treatment

Time frame
The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment
3

1-year PFS rate

the proportion of the total patients who does not with tumor progression or death within 1 year from enrollment.

Time frame
The proportion of patients with tumor progression or death from enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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