Advanced Colorectal CarcinomaPhase 4NCT05894694
Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
A Phase 4 study testing first-line scheme+compound kushen injection and palliative care group first-line scheme in people with Advanced Colorectal Carcinoma, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma
- What is being tested?
- first-line scheme+compound kushen injection and palliative care group first-line scheme
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
Jie Li
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Colorectal Carcinoma
- Being tested
- first-line scheme+compound kushen injection, palliative care group first-line scheme
- Keywords
- Compound kushen Injection, Traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first-line scheme+compound kushen injectionDrug
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.
palliative care group first-line schemeDrug
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| first-line scheme + compound kushen injection | Experimental | Compound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+ Receives: Drug: first-line scheme+compound kushen injection |
| first-line scheme | Other | first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab) Receives: Drug: palliative care group first-line scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months
Secondary outcomes (3)
OS
Overall survival
Measured: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
1-year survival rate
The probability of patients surviving more than 1 year after treatment
Measured: 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 the total patients who does not with tumor progression or death within 1 year from enrollment.
Measured: The proportion of patients with tumor progression or death from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start27 Sep 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894694
- Sponsor's protocol ID
- 2023-063-KY
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39741233
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform
- ClinicalTrials.gov ID
- NCT05894694
- Acronym / sponsor ID
- 2023-063-KY
- Conditions
- Advanced Colorectal Carcinoma
- Keywords
- Compound kushen Injection, Traditional Chinese medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first-line scheme + compound kushen injection | Experimental | Drug: first-line scheme+compound kushen injectionCompound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+ |
| first-line scheme | Other | Drug: palliative care group first-line schemefirst-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Combined with other malignant primary tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first-line scheme+compound kushen injectionFOLFOX/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. | Drug | first-line scheme + compound kushen injection |
| palliative care group first-line schemeFOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab | Drug | first-line scheme |
Primary outcome
PFS
Time frame: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months
Progression Free Survival
3 secondary outcomes
OS
Time frame: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
1-year survival rate
Time frame: 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
Time frame: The proportion of patients with tumor progression or death from enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 39741233Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing first-line scheme+compound kushen injection and palliative care group first-line scheme in people with Advanced Colorectal Carcinoma, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jie Li (88001711, qfm2020jieli@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.