TAS 102NCT05993702
TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer
An observational study of TAS 102 and Regorafenib, run by China Medical University, China.
Trial summary
This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TAS 102, Regorafenib, Fruquintinib
- What is being tested?
- regorafenib and fruquintinib
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients between the ages of 18-75 years
Who may be able to join
- Male or female patients between the ages of 18-75 years;
- Patients with colorectal cancer diagnosed by histology or cytology;
- Patients with metastatic colorectal cancer who have failed two or more standard therapies; patients are permitted to have received prior chemotherapy with fluorouracil, oxaliplatin, irinotecan, and other regimens, patients are permitted to receive EGFR and/or VEGF inhibitors, and patients are permitted to have received prior immunotherapy;
- Have at least one measurable lesion according to the solid tumour efficacy evaluation criteria RECIST version 1.1; the measurable lesion should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets the RECIST 1.1 criteria);
- ECOG PS score: 0 to 1; expected survival more than 3 months;
- Oral medication is available;
- have adequate organ and bone marrow function, i.e., meet the following criteria:
- Criteria for routine blood tests need to be met: Haemoglobin level (HB) ≥ 90 g/L (no transfusion within 28 days); Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥ 100×109/L. (2) Biochemical tests need to meet the following criteria: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) ; ALT and AST ≤ 2.5 ULN (ALT and AST ≤ 5 ULN if liver metastases are present); Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min; (Cockcroft-Gault formula) (3) Adequate coagulation function, defined as International Normalised Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; 8) Pregnant or breastfeeding patients: 1) Females and males of childbearing potential must agree to use adequate contraception prior to entering the programme until at least 8 weeks after the last dose of study drug. The Investigator or designee is required to advise subjects on how to achieve adequate contraception. Appropriate contraception is defined in the study as any medically recommended method (or combination of methods) based on standard treatment 2) Women of childbearing age must have a negative serum or urine pregnancy test confirmed within 7 days prior to initiating treatment and must agree to record a negative result prior to entering the study.
Who cannot join
- study:
- Patients with abnormal coagulation or a tendency to gastrointestinal bleeding on thrombolytic or anticoagulant medication, including active peptic ulcers with fecal occult blood++, vomiting blood or black stools within 3 months.
- Prior or concurrent cancers with a primary site or histology different from CRC within the year of enrolment, with the exception of cured in situ cervical cancer, non-melanoma skin cancers, and superficial bladder tumours:staging Ta, Tis and T1 .
- Arterial or venous thrombotic or embolic events, such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis, or pulmonary embolism (except for appropriately treated catheter-associated venous thrombosis occurring more than 1 month after initiation of therapy), have occurred within 6 months prior to the start of treatment.
- Major surgery, biopsy or significant traumatic injury within 28 days prior to the start of investigational therapy.
- Unhealed wounds, ulcers, or fractures.
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- Patients with brain metastases and/or carcinomatous meningitis.
- Congestive heart failure >New York Heart Association (NYHA) class 2.
- Unstable angina (angina at rest), new onset angina (within the last 3 months). Myocardial infarction within 6 months prior to the start of treatment.
- Arrhythmia requiring antiarrhythmic therapy (beta-blockers or digoxin permitted). Uncontrolled hypertension. (Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical therapy).
- Patients with pheochromocytoma
- Pleural effusion or ascites causing respiratory restriction (≥ CTCAE grade 2 dyspnoea)
- Active infection >NCI CTCAE2 level
- interstitial lung disease with signs and symptoms at the time of informed consent
- known hypersensitivity to any of the drugs in the study, to drugs of the same class as the study drug, or to excipients in dosage forms
- use of CYP3A4 inhibitors or inducers
- Participation in another clinical trial within 4 weeks prior to enrolment and receipt of the investigational drug and any concomitant therapy containing the investigational drug
- have received radiotherapy within 4 weeks prior to enrolment and the lesion under observation in this study is in the target area of radiotherapy
- Subjects with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within one year prior to screening
- Subjects with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (>10mg/day of prednisone or other equipotent hormones).
- Received any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, neocoronavirus vaccine, etc.) within 4 weeks prior to enrolment.
- Pregnancy or breastfeeding
- Persistent proteinuria >3.5 g/24 hours by measurement of urine protein-creatinine ratio (grade 3, NCI-CTCAE version 5.0) in random urine samples.
- Human immunodeficiency virus (HIV) positive
- Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA copy number positive (quantitative test ≥1000 cps/ml)
- Positive blood test for chronic hepatitis C (HCV antibody positive)
- renal failure requiring haemodialysis or peritoneal dialysis
- Dehydration ≥ CTCAE Version 5.0 Level 1
- Persons who are legally incompetent.
- Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the Informed Consent Form (ICF) by the subject, or make participation in this clinical trial inappropriate.
Trial locations and contacts
No sites are listed yet.
Ling Xu, PhD contact
About this study
Official title: Single-arm, Multicentre Real-world Observational Study of TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer
This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.
Read the detailed description
This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.The purpose of the study is to evaluate the efficacy and safety of TAS-102 in combination with a regimen of regorafenib or fruquintinib for the treatment of advanced colorectal cancer in the third line and above.
- Conditions
- TAS 102, Regorafenib, Fruquintinib, Gastrointestinal Tumours
- Being tested
- regorafenib, fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regorafenibDrug
Also called baiwange
(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle)
fruquintinibDrug
Also called elunate
TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; or Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 in combination with regorafenib | (TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle) Receives: Drug: regorafenib | |
| TAS-102 in combination with fruquintinib | TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle. Receives: Drug: fruquintinib |
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 (3)
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
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 posted15 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAS 102Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- 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
- NCT05993702
- Sponsor's protocol ID
- PRAY
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Aug 2023
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multicentre Real-world Observational Study of TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05993702
- Acronym / sponsor ID
- PRAY
- Conditions
- TAS 102, Regorafenib, Fruquintinib, Gastrointestinal Tumours
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Aug 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.
This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.
Detailed description
This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.The purpose of the study is to evaluate the efficacy and safety of TAS-102 in combination with a regimen of regorafenib or fruquintinib for the treatment of advanced colorectal cancer in the third line and above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-102 in combination with regorafenib | – | Drug: regorafenib(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle) |
| TAS-102 in combination with fruquintinib | – | Drug: fruquintinibTAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients between the ages of 18-75 years
Key inclusion criteria (8 listed)
- Male or female patients between the ages of 18-75 years;
- Patients with colorectal cancer diagnosed by histology or cytology;
- Patients with metastatic colorectal cancer who have failed two or more standard therapies; patients are permitted to have received prior chemotherapy with fluorouracil, oxaliplatin, irinotecan, and other regimens, patients are permitted to receive EGFR and/or VEGF inhibitors, and patients are permitted to have received prior immunotherapy;
- Have at least one measurable lesion according to the solid tumour efficacy evaluation criteria RECIST version 1.1; the measurable lesion should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets the RECIST 1.1 criteria);
- ECOG PS score: 0 to 1; expected survival more than 3 months;
Key exclusion criteria (30 listed)
- study:
- Patients with abnormal coagulation or a tendency to gastrointestinal bleeding on thrombolytic or anticoagulant medication, including active peptic ulcers with fecal occult blood++, vomiting blood or black stools within 3 months.
- Prior or concurrent cancers with a primary site or histology different from CRC within the year of enrolment, with the exception of cured in situ cervical cancer, non-melanoma skin cancers, and superficial bladder tumours:staging Ta, Tis and T1 .
- Arterial or venous thrombotic or embolic events, such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis, or pulmonary embolism (except for appropriately treated catheter-associated venous thrombosis occurring more than 1 month after initiation of therapy), have occurred within 6 months prior to the start of treatment.
- Major surgery, biopsy or significant traumatic injury within 28 days prior to the start of investigational therapy.
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: baiwange(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle) | Drug | TAS-102 in combination with regorafenib |
| fruquintinibAlso: elunateTAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; or Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle. | Drug | TAS-102 in combination with fruquintinib |
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
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 15 Aug 2023.
- 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?
An observational study of TAS 102 and Regorafenib, 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 8 inclusion and 30 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 15 Aug 2023. 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.
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 15 Aug 2023.