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

NCT05894694 | Recruiting Phase 4 DMC

• 1 other identifier: 2023-063-KY
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Colorectal Carcinoma

Keywords

Compound kushen Injection; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months

Secondary Outcomes (3)

• OS

  The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months

• 1-year survival rate

  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

  The proportion of patients with tumor progression or death from enrollment.

Study Arms (2)

first-line scheme + compound kushen injection

EXPERIMENTAL

Compound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+

Drug: first-line scheme+compound kushen injection

first-line scheme

OTHER

first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)

Drug: palliative care group first-line scheme

Interventions

first-line scheme+compound kushen injection DRUG

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.

first-line scheme + compound kushen injection

palliative care group first-line scheme DRUG

FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

first-line scheme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Central Study Contacts

jie Li

CONTACT

88001711; qfm2020jieli@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: June 8, 2023
• Study Start: September 27, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)