RegorafenibPhase 1/2NCT05426811
Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients
A Phase 1/2 study testing Regorafenib and Raltitrexed in people with Regorafenib and Raltitrexed, run by China Medical University, China.
Trial summary
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regorafenib, Raltitrexed, Colorectal Neoplasms
- What is being tested?
- Regorafenib and Raltitrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Dec 2025
- Phase
- Phase 1/2
- 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
- Sign a consent form
- Age> 18 years
- Pathological diagnosis as metastatic colorectal adenocarcinoma
- Metastatic colorectal cancer with disease progression after 1st and 2nd line treatment；Received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan, patients are allowed to receive EGFR and/or VEGF inhibitors, patients are allowed to receive immunotherapy.
- Measurable disease according to RECIST
- ECOG score 0-1 points
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- Life expectancy ≥3 months
- ALT and AST< 2.5 times the upper limit of normal (ULN), patients with liver metastases < 5 times ULN
- Serum albumin ≥ 3.0g/ dL
- Serum ALP <2.5 times ULN
- Total bilirubin <l.5mg / dL
- Estimated creatinine clearance (CLcr) ≥30mL/min as calculated using the Cockcroft-Gault equation
- Lipase≤1.5x the ULN
- Neutrophil absolute count (ANC) ≥1500/mm³, hemoglobin (Hb)>9g/dl, platelets> 10000/mm³
- Pregnant or breastfeeding patients. (1) Women and men of childbearing potential must agree to use appropriate contraception prior to entering the program until at least 8 weeks after the last dose of study drug. The investigator or designee is required to advise the subject on how to achieve appropriate contraception. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) according to standard treatment 2) Women of childbearing age must confirm a negative serum or urine pregnancy test within 7 days prior to initiating treatment and must agree to record a negative result prior to entering the study
Who cannot join
- Prior exposure to any VEGFR tyrosine kinase inhibitor (e.g., regorafenib, apatinib, anlotinib, furoquinitinib, etc.) therapy
- Received raltitrexed in the previous treatment
- Patients with abnormal coagulation function or those treated with thrombolytic or anticoagulant drugs with a tendency to bleed from the gastrointestinal tract, including active peptic ulcer with fecal occult blood ++, vomiting blood or black stool within 3 months
- Prior or concurrent cancers with a different primary site or histology than CRC within the enrollment year, except cured in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta, Tis, and T1
- Arterial or venous thrombotic or embolic events such ascerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombos is occurring more than one month before the start of study medication)
- Major surgery, biopsy or significant traumatic damage within 28 days prior to the start of investigational treatment
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- Non-healing wound, non-healing ulcer, or non-healing bone fracture.
- Patients with brain metastases and/or cancerous meningitis
- Congestive heart failure > New York Heart Association (NYHA) class 2.
- Unstable angina (angina symptoms at rest), new onset angina (occurred within the last 3 months). Myocardial infarction within 6 months prior to the start of treatment.
- Arrhythmias requiring antiarrhythmic therapy (beta-blockers or digoxin allowed)
- Uncontrolled hypertension. (Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment)
- Patients with pheochromocytoma
- Pleural effusion or ascites causing restricted breathing (≥ CTCAE grade 2 dyspnea)
- Known to have dihydropyrimidine dehydrogenase deficiency
- Ongoing infection > Grade 2 NCI CTCAE
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- Known hypersensitivity to any of the stidy drugs, study drug classes,or excipients in the formulation
- The use of CYP3A4 inhibitors or inducers
- Participation in another clinical trial within 4 weeks prior to enrollment and receipt of the investigational drug and any concomitant therapy containing the investigational drug
- Received radiotherapy within 4 weeks prior to enrollment and the lesions observed in this study were in the target area of radiotherapy
- Subjects with active tuberculosis (TB) who are on anti-tuberculosis treatment, or who have received anti-tuberculosis treatment within one year prior to screening
- Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (doses >10 mg/day of prednisone or other isotonic hormones)
- Received any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, Neocon vaccine, etc.) within 4 weeks prior to enrollment
- Pregnancy or breastfeeding
- Persistent proteinuria >3.5g/24 hours by measuring the urine protein-creatinine ratio in random urine samples (grade 3, NCI-CTCAE version 5.0)
- Positive for Human Immunodeficiency Virus (HIV)
- Positive hepatitis B virus surface antigen (HBsAg) with positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml)
- Positive blood screen for chronic hepatitis C (positive for HCV antibodies)
- Renal failure requiring hemodialysis or peritoneal dialysis
- The degree of dehydration ≥ CTCAE version 5.0 level 1
- Persons without legal capacity
- Any other clinically significant disease or condition that, in the opinion of the investigator, could affect compliance with the protocol, or affect the subject's ability to sign an informed consent form (ICF), or is inappropriate for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet.
Ling Xu, PhD contact
About this study
Official title: Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients：An Open-label, Single-arm, Multicenter Phase I/II Study
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.
Read the detailed description
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.This Phase Ib/II study consists of two parts, Phase Ib, an open-ended, single-arm, multi-centre, dose-escalation study evaluating regorafenib, and Phase II, an open-label, multi-centre study evaluating the efficacy and safety of regorafenib in combination with raltitrexed.The primary study endpoint: progression-free survival (PFS).The secondary end endpoints include ORR (overall effectiveness of tumour treatment)，DCR (disease control rate)，3 month/6 month/9 month/12 month survival OS%，OS (overall survival)，incidence and severity of adverse events (AEs), serious adverse events (SAEs).
- Conditions
- Regorafenib, Raltitrexed, Colorectal Neoplasms, Third-line Treatment
- Being tested
- Regorafenib, Raltitrexed
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called Stivarga
Regorafenib:120mg/d，Po，qd,d1-d21，Every 4 weeks
RaltitrexedDrug
Also called Sai wei jian
Raltitrexed:3mg/㎡，ivgtt，d1，Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib combined with Raltitrexed | Experimental | Regorafenib:
120mg/d，Po，qd,d1-d21，Every 4 weeks
Raltitrexed:
3mg/㎡，ivgtt，d1，Every 3 weeks Receives: Drug: Regorafenib; Drug: Raltitrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: one year
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: one year
Disease Control Rate (DCR)
Determined using RECIST v1.1 criteria.
Measured: one year
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Measured: two years
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegorafenibStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province, Anshan Tumor Hospital, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Benxi Cental Hospital
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426811
- Sponsor's protocol ID
- REGORAL
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients：An Open-label, Single-arm, Multicenter Phase I/II Study
- ClinicalTrials.gov ID
- NCT05426811
- Acronym / sponsor ID
- REGORAL
- Conditions
- Regorafenib, Raltitrexed, Colorectal Neoplasms, Third-line Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province, Anshan Tumor Hospital, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Benxi Cental Hospital
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jun 2022 (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.
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.
Detailed description
This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.This Phase Ib/II study consists of two parts, Phase Ib, an open-ended, single-arm, multi-centre, dose-escalation study evaluating regorafenib, and Phase II, an open-label, multi-centre study evaluating the efficacy and safety of regorafenib in combination with raltitrexed.The primary study endpoint: progression-free survival (PFS).The secondary end endpoints include ORR (overall effectiveness of tumour treatment)，DCR (disease control rate)，3 month/6 month/9 month/12 month survival OS%，OS (overall survival)，incidence and severity of adverse events (AEs), serious adverse events (SAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Regorafenib combined with Raltitrexed | Experimental | Drug: Regorafenib, Drug: RaltitrexedRegorafenib: 120mg/d，Po，qd,d1-d21，Every 4 weeks Raltitrexed: 3mg/㎡，ivgtt，d1，Every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sign a consent form
- Age> 18 years
- Pathological diagnosis as metastatic colorectal adenocarcinoma
- Metastatic colorectal cancer with disease progression after 1st and 2nd line treatment；Received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan, patients are allowed to receive EGFR and/or VEGF inhibitors, patients are allowed to receive immunotherapy.
- Measurable disease according to RECIST
Key exclusion criteria (33 listed)
- Prior exposure to any VEGFR tyrosine kinase inhibitor (e.g., regorafenib, apatinib, anlotinib, furoquinitinib, etc.) therapy
- Received raltitrexed in the previous treatment
- Patients with abnormal coagulation function or those treated with thrombolytic or anticoagulant drugs with a tendency to bleed from the gastrointestinal tract, including active peptic ulcer with fecal occult blood ++, vomiting blood or black stool within 3 months
- Prior or concurrent cancers with a different primary site or histology than CRC within the enrollment year, except cured in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta, Tis, and T1
- Arterial or venous thrombotic or embolic events such ascerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombos is occurring more than one month before the start of study medication)
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 |
|---|---|---|
| RegorafenibAlso: StivargaRegorafenib:120mg/d，Po，qd,d1-d21，Every 4 weeks | Drug | Regorafenib combined with Raltitrexed |
| RaltitrexedAlso: Sai wei jianRaltitrexed:3mg/㎡，ivgtt，d1，Every 3 weeks | Drug | Regorafenib combined with Raltitrexed |
Primary outcome
Progression-free Survival (PFS)
Time frame: one year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
Overall Survival (OS)
Time frame: two years
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- 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. This study is not recruiting at the moment.
Ling Xu, PhD contact
Yunpeng Liu, PhD principal investigator
First Hospital of China Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regorafenib and Raltitrexed in people with Regorafenib and Raltitrexed, run by China Medical University, 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 15 inclusion and 33 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 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yunpeng Liu, PhD (86-24-83282312, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: one year). 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 29 Jun 2022.