NCT05894694 Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
| NCT ID | NCT05894694 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Condition | Advanced Colorectal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-09-27 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 320 participants in total. It began in 2023-09-27 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05894694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05894694 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05894694 currently recruiting?
Yes, NCT05894694 is actively recruiting participants. Contact the research team at qfm2020jieli@yeah.net for enrollment information.
Where is the NCT05894694 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05894694 clinical trial?
NCT05894694 is sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The trial plans to enroll 320 participants.