Clinical trial NCT05894694: Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
Official title: Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Advanced Colorectal Carcinoma
Keywords: Compound kushen Injection
Traditional Chinese medicine
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: PFS
timeFrame: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: OS
timeFrame: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
measure: 1-year survival rate
timeFrame: The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment
measure: 1-year PFS rate
timeFrame: The proportion of patients with tumor progression or death from enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
References: