Using Compound Kushen Injection to Treat Advanced Colorectal Cancer

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

This study is testing if adding a compound kushen injection to standard treatment can help people with advanced colorectal cancer live longer without their disease getting worse.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT05894694 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced colorectal cancer who are receiving first-line therapy and have a good performance status.

Not a fit: Patients with other primary malignancies, those with specific genetic markers like MSI-H/dMMR, or those who have undergone recent cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival outcomes for patients with advanced colorectal cancer.

How similar studies have performed: While the use of traditional Chinese medicine in cancer treatment is gaining interest, this specific approach with compound kushen injection is relatively novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Beijing

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

Study contacts

• Study coordinator: jie Li

Conditions Advanced Colorectal Carcinoma; Compound kushen Injection; Traditional Chinese medicine