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Recruiting NCT05894694

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

Phase IV Interventional Advanced Colorectal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: first-line scheme+compound kushen injection, palliative care group first-line scheme.
Who it may be relevant to
Registry conditions: Advanced Colorectal Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform

Overview

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

Detailed description

This study include a multi-center, randomized, parallel controlled clinical trial. The randomized clinical trial will enroll approximately 320 patients. Participants will be randomly divided into experimental (n=160) and control groups (n=160). Patients in the experimental group was treated with first-line scheme + compound kushen injection. Patients in the control group will receive first-line scheme. The primary endpoint is PFS. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Interventions

  • Drug first-line scheme+compound kushen injection
    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.
  • Drug palliative care group first-line scheme
    FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Primary outcome measures

  • PFS [Time frame: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months]
Secondary outcome measures (3)
  • OS [Time frame: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months]
  • 1-year survival rate [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]
  • 1-year PFS rate [Time frame: The proportion of patients with tumor progression or death from enrollment.]

Eligibility criteria

Inclusion criteria

① Patients with advanced CRC confirmed by pathology or cytology and receiving first-line therapy;② Aged ≥ 18 years old, male or female;③ ECOG score 0-2 points;④ Expected survival ≥ 3 months;⑤ According to RECIST1.1 criteria, at least one detectable lesion;⑥ Voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up.

Exclusion criteria

  • 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;
  • Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ Psychiatric patients; ⑦ Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ Patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ Patients who are known to be allergic to or intolerant of study drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guang 'anmen Hospital, China Academy of Chinese Medical Sciences — Beijing

Publications

  • Wu J, Ge Y, Zhu G, Gao R, Zhu X, Zhang Y, Li J. Combination of Compound Kushen injection with first-line treatment versus first-line treatment alone for advanced colorectal cancer: a study protocol for a multicenter, openlabel, randomized controlled trial. BMC Complement Med Ther. 2024 Dec 31;24(1):429. doi: 10.1186/s12906-024-04725-6. PMID 39741233

Identifiers

NCT: NCT05894694 · 2023-063-KY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗