NCT05894694RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- 27 Sept 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Diseases
- Colorectal cancer
- NCT number
- NCT05894694
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 320
- From 27 Sept 2023 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guang 'anmen Hospital, China Academy of Chinese Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.