Unresectable or Metastatic Colorectal CancerPhase 2NCT05797883
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
A Phase 2 study testing FOLFOX/FOLFIRI in people with Unresectable or Metastatic Colorectal Cancer, run by China Medical University, China at 1 site in China.
Trial summary
To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Colorectal Cancer
- What is being tested?
- FOLFOX/FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female, ≥18 years old;
- Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions;
- Have at least one measurable lesion according to RECIST 1.1 standards;
- ECOG PS score: 0-2;
- Expected survival greater than 3 months;
- Routine blood routine, liver and kidney function, electrocardiogram and other routine tests were basically normal, no contraindications of chemotherapy;
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits;
- Researchers believe treatment can benefit.
Who cannot join
- A proven allergy to the test drug and/or its excipients;
- Pregnant or lactating women;
- Patients judged by the investigator to be unsuitable for inclusion in this study;
Trial locations and contacts
1 site in 1 country.
Qian Dong contact
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Qian Dong, Doctor, 17309815028, dongqian08@163.com
Jingdong Zhang, Doctor
About this study
Official title: Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer
- Being tested
- FOLFOX/FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX/FOLFIRIDrug
mFOLFOX6 ：oxaliplatin 85mg/m² IV infusion 2h d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); FOLFIRI ：Irinotecan 180mg/m ² static pulse infusion 30min~90min d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+ Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); The combination of cetuximab/bevacizumab and other targeted agents depends on the patient.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX/FOLFIRI | Experimental | q2w, after 8 cycles of medication or patient intolerance or disease progression; Receives: Drug: FOLFOX/FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
Measured: 2 years
Secondary outcomes (2)
Progression-free survival (PFS)
The date from random to the first occurrence of disease progression or death from any cause, whichever comes first
Measured: 2years
Disease control rate (DCR)
The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Aug 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable or Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingdong Zhang, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797883
- Sponsor's protocol ID
- HL-ZY-002
- Status last verified
- Jan 2023
- First submitted
- 22 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05797883
- Acronym / sponsor ID
- HL-ZY-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 4 Apr 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 observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX/FOLFIRI | Experimental | Drug: FOLFOX/FOLFIRIq2w, after 8 cycles of medication or patient intolerance or disease progression; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, ≥18 years old;
- Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions;
- Have at least one measurable lesion according to RECIST 1.1 standards;
- ECOG PS score: 0-2;
- Expected survival greater than 3 months;
Key exclusion criteria (3 listed)
- A proven allergy to the test drug and/or its excipients;
- Pregnant or lactating women;
- Patients judged by the investigator to be unsuitable for inclusion in this study;
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 |
|---|---|---|
| FOLFOX/FOLFIRImFOLFOX6 ：oxaliplatin 85mg/m² IV infusion 2h d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); FOLFIRI ：Irinotecan 180mg/m ² static pulse infusion 30min~90min d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+ Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); The combination of cetuximab/bevacizumab and other targeted agents depends on the patient. | Drug | FOLFOX/FOLFIRI |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 2years
Disease control rate (DCR)
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Related trials for Unresectable or Metastatic Colorectal Cancer
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma
RecruitingPhase 3
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
Colorectal Neoplasms
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
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. This study is not recruiting at the moment.
Qian Dong contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX/FOLFIRI in people with Unresectable or Metastatic Colorectal Cancer, run by China Medical University, China 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingdong Zhang (+86-13804027878, zhangjingdong@cancerhosp-ln-cmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.