Using Compound Kushen Injection to Treat Advanced Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of compound kushen injection in patients with advanced colorectal cancer. It is a multi-center, randomized, parallel controlled trial involving approximately 320 participants, who will be divided into an experimental group receiving the injection alongside standard first-line therapy and a control group receiving only the standard therapy. The primary endpoint of the study is progression-free survival (PFS), and the trial adheres to ethical guidelines and good clinical practice. Informed consent is obtained from all participants prior to enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: jie Li
• Email: qfm2020jieli@yeah.net
• Phone: 88001711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.