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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Colorectal Carcinoma
• Intervention / Treatment: Drug: palliative care group first-line scheme; Drug: first-line scheme+compound kushen injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: jie Li; Phone Number: 88001711; Email: qfm2020jieli@yeah.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Jie Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: first-line scheme + compound kushen injection; Compound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+	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.
Other: first-line scheme; first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)	Drug: palliative care group first-line scheme; FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year survival rate	The probability of patients surviving more than 1 year after treatment	The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment
OS	Overall survival	The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
1-year PFS rate	the proportion of the total patients who does not with tumor progression or death within 1 year from enrollment.	The proportion of patients with tumor progression or death from enrollment.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Traditional Chinese medicine; Compound kushen Injection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2023-063-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No