Colorectal CancerPhase 2NCT06293014
TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
A Phase 2 study testing TAS-102+bevacizumab and Standard chemotherapy+bevacizumab in people with Colorectal Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TAS-102+bevacizumab and Standard chemotherapy+bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 28 Nov 2026
- Phase
- Phase 2
- 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
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age ≥18 years old;
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- After receiving 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab second-line induction therapy, the patients are confirmed as CR, PR, or SD according to RECIST 1.1 criteria;
- The interval between the last second-line induction therapy and randomization is not more than 6 weeks;
- At least one measurable lesion according to RECIST 1.1 criteria;
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- ECOG Performance Status 0-2;
- Estimated life expectancy ≥12 weeks;
- Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization);
- Women of child-bearing potential must agree to abstain from sex (heterosexual intercourse) or use a reliable, effective method of contraception from the time they provide informed consent until at least 90 days after the last dose of study drug is administered. Serum or urine HCG test must be negative. And must be non-lactating;
- Male participants whose partner is a woman of child-bearing potential must agree to abstain from sex or use a reliable,effective method of contraception from the time they sign an informed consent form until at least 90 days after the last dose of study drug is administered. Male subjects also have to agree not to donate sperm during the same period.
Who cannot join
- Any CTCAE grade 1 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
- Known history or evidence of interstitial lung disease or active noninfectious pneumonia;
- Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;
- Have bleeding tendency and high risk of bleeding;
- Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
- Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;
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- Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;
- Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;
- Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;
- Patients with congenital or acquired immune deficiency (such as HIV infection);
- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV virus copy number > upper limit of normal);
- Known brain and/or leptomeningeal metastases. All subjects should receive brain CT/MRI to exclude brain metastases;
- Active infection or fever of unknown origin > 38.5 ° C within 2 weeks before the first dose (tumor-related fever, as judged by the investigator, was eligible);
- Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
- Have poorly controlled cardiac clinical symptoms or disease；
- Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Pregnant or lactating women;
- Patients with genotype MSI-H;
- Prior treatment with TAS-102;
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before study treatment;
- The investigator assessed that it is not appropriate to participate in the study.
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
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, 450008
Ying Liu, MD, +86-13783604602, Yaya7207@126.com
About this study
Official title: A Randomized, Open-label, Multicentre Clinical Study of TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
Read the detailed description
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, DoR, PFS, OS, safety and patient reported outcomes.
This study plans to enroll 224 patients with advanced colorectal cancer who have previously achieved disease control after second-line induction therapy with standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab.
The subjects will be randomly assigned in a 1:1 ratio to the TAS-102 combined with bevacizumab second-line maintenance treatment group (experimental group) and the standard chemotherapy combined with bevacizumab second-line continuous treatment group (control group).
- Conditions
- Colorectal Cancer
- Being tested
- TAS-102+bevacizumab, Standard chemotherapy+bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102+bevacizumabDrug
Also called Trifluridine and Tipiracil Hydrochloride Tablets; bevacizumab
TAS-102 35mg/m2, PO, D1-5, repeated every 14 days; Bevacizumab 5mg/kg, IV, D1, repeated every 14 days; Q4w.
Standard chemotherapy+bevacizumabDrug
Also called Bevacizumab
Standard chemotherapy (chemotherapy regimen based on investigator's choice, including FOLFIRI, FOLFOX, or CAPEOX); Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| second-line maintenance treatment group | Experimental | TAS-102 combined with bevacizumab Receives: Drug: TAS-102+bevacizumab |
| second-line continuous treatment group | Active comparator | Standard chemotherapy (FOLFOX，FOLFIRI or CAPEOX) combined with bevacizumab Receives: Drug: Standard chemotherapy+bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF)
TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
Measured: up to approximately 2 years.
Secondary outcomes (8)
Objective response rate (ORR)
ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.
Measured: up to approximately 2 years.
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).
Measured: up to approximately 2 years.
Duration of Response (DoR)
Response will be determined by investigator using RECIST 1.1.
Measured: up to approximately 2 years.
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Measured: up to approximately 2 years.
Overall survival（OS）
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: up to approximately 2 years.
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Measured: up to approximately 2 years.
European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L)
EQ-5D-5L is an abbreviation for "European Quality of life - 5 Dimensions - 5 Level" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst).
Measured: up to approximately 2 years.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during study treatment.
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
Measured: up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start23 Feb 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ying Liu, Henan Cancer Hospital
- Investigators
- Ying Liu, Dr, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293014
- Sponsor's protocol ID
- QLMA-CRC-IIT-001
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicentre Clinical Study of TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06293014
- Acronym / sponsor ID
- QLMA-CRC-IIT-001
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 5 Mar 2024 (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 study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
Detailed description
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, DoR, PFS, OS, safety and patient reported outcomes.
This study plans to enroll 224 patients with advanced colorectal cancer who have previously achieved disease control after second-line induction therapy with standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab.
The subjects will be randomly assigned in a 1:1 ratio to the TAS-102 combined with bevacizumab second-line maintenance treatment group (experimental group) and the standard chemotherapy combined with bevacizumab second-line continuous treatment group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| second-line maintenance treatment group | Experimental | Drug: TAS-102+bevacizumabTAS-102 combined with bevacizumab |
| second-line continuous treatment group | Active comparator | Drug: Standard chemotherapy+bevacizumabStandard chemotherapy (FOLFOX，FOLFIRI or CAPEOX) combined with bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age ≥18 years old;
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- After receiving 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab second-line induction therapy, the patients are confirmed as CR, PR, or SD according to RECIST 1.1 criteria;
- The interval between the last second-line induction therapy and randomization is not more than 6 weeks;
Key exclusion criteria (21 listed)
- Any CTCAE grade 1 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
- Known history or evidence of interstitial lung disease or active noninfectious pneumonia;
- Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;
- Have bleeding tendency and high risk of bleeding;
- Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
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 |
|---|---|---|
| TAS-102+bevacizumabAlso: Trifluridine and Tipiracil Hydrochloride Tablets; bevacizumabTAS-102 35mg/m2, PO, D1-5, repeated every 14 days; Bevacizumab 5mg/kg, IV, D1, repeated every 14 days; Q4w. | Drug | second-line maintenance treatment group |
| Standard chemotherapy+bevacizumabAlso: BevacizumabStandard chemotherapy (chemotherapy regimen based on investigator's choice, including FOLFIRI, FOLFOX, or CAPEOX); Bevacizumab | Drug | second-line continuous treatment group |
Primary outcome
Time to treatment failure (TTF)
Time frame: up to approximately 2 years.
TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
8 secondary outcomes
Objective response rate (ORR)
Time frame: up to approximately 2 years.
Disease control rate (DCR)
Time frame: up to approximately 2 years.
Duration of Response (DoR)
Time frame: up to approximately 2 years.
Progression-free survival (PFS)
Time frame: up to approximately 2 years.
Overall survival（OS）
Time frame: up to approximately 2 years.
Adverse Events
Time frame: up to approximately 2 years.
European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L)
Time frame: up to approximately 2 years.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
Time frame: up to approximately 2 years.
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 5 Mar 2024.
- 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.
Ying Liu, Dr principal investigator
Henan Cancer Hospital
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 TAS-102+bevacizumab and Standard chemotherapy+bevacizumab in people with Colorectal Cancer, run by Henan Cancer Hospital 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 11 inclusion and 21 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 5 Mar 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 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?
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 Ying Liu, Dr (13783604602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (TTF) (time frame: up to approximately 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 5 Mar 2024.