First-line TreatmentPhase 2TOBACONCT05077839
Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC
A Phase 2 study testing Trifluridine/Tipiracil in people with First-line Treatment and Advanced Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First-line Treatment, Advanced Colorectal Cancer
- What is being tested?
- Trifluridine/Tipiracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 2025
- 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
- Signed the informed consent.
- Age ≥18.
- Colonic adenocarcinoma confirmed histologically or histopathologically.
- No previous chemotherapy for advanced colorectal cancer, or patients who had received adjuvant chemotherapy after radical resection and relapsed 12 months after the completion of adjuvant chemotherapy.
- ECOG physical status score is 0 or 1.
- There are measurable metastatic lesions according to RECIST version 1.1.
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- Appropriate organ function according to the following laboratory test values obtained within 7 days prior to use on Day 1 of Cycle 1:
- Hemoglobin value ≥9.0g/dL.
- Absolute neutrophil count ≥1,500/mm3 (≥1.5*109/L).
- Platelet count ≥100,000/mm3 (≥100*109/L).
- Total serum bilirubin ≤1.5* upper normal limit (ULN).
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5* upper limit of normal value (ULN). If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤5*ULN.
- Serum creatinine ≤1.5 times * upper limit of normal (ULN) or creatinine clearance ≥50ml/min.
- The results of urine or serum pregnancy test within 7 days prior to treatment were negative. Women who are likely to become pregnant and men must agree to take adequate contraceptive measures during the study period until 6 months after the end of medication.
- Survival is expected to be at least 3 months.
- Willing and able to follow research procedures and visit plans.
Who cannot join
- Has a serious illness or medical condition, including but not limited to the following:
- There are other active malignant tumors at the same time, excluding those that have not occurred for more than 5 years or carcinoma in situ that can be cured by adequate treatment.
- Known presence of brain metastases or leptomeningeal metastases.
- Systemic active infection (i.e., infection causes body temperature ≥38℃).
- Clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease.
- Uncontrolled diabetes.
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- Severe/unstable angina, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure.
- Gastrointestinal bleeding of clinical significance.
- Known presence of human immunodeficiency virus (HIV) or acquired routine immunodeficiency syndrome (AIDS) -associated disease, or active hepatitis B or C.
- There are psychiatric disorders that may increase the risk associated with participating in the study or taking the study drugs, or may interfere with the interpretation of the study results.
- Any of the following treatments were received within a specific time frame before the study drug was taken:
- Major surgery in the previous 4 weeks. (Major surgery refers to laparotomy, thoracotomy, and laparoscopic resection of internal organs. On-off of abdomen was excluded)
- Radiotherapy with extended field within the previous 4 weeks or radiotherapy with limited field within the previous 2 weeks.
- Any investigational drugs within the previous 4 weeks.
- Presence of neurotoxicity of CTCAE grade 2 or above caused by adjuvant therapy.
- Pregnant or lactating women.
- The researcher did not consider it appropriate to enter the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yi Ba, MD, 022-23340123-1053, bayi@tjmuch.com
About this study
Official title: Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer (TOBACO): a Randomized, Controlled, Phase II Study
This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital.
Patients with advanced colorectal cancer will be randomly assigned (1:1) to trifluridine/tipiracil combined with oxaliplatin and bevacizumab (experimental group) or XELOX plus bevacizumab (control group) after signing informed consent. In this study, 184 patients will be enrolled, 92 patients will receive trifluridine/tipiracil combined with oxaliplatin and bevacizumab and 92 patients will receive standard therapy.
Read more
In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. Patients enrolled in this group could acquire trifluridine/tipiracil free of charge.
The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment.
Patients received regular and periodic reviews, with imaging evaluations every 8 weeks. Safety will be evaluated by AE and laboratory tests. All patients were followed up every 3 months until death according to the plan.
- Conditions
- First-line Treatment, Advanced Colorectal Cancer
- Being tested
- Trifluridine/Tipiracil
- Keywords
- Trifluridine/tipiracil, first-line treatment, advanced colorectal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/TipiracilDrug
Also called TAS-102
Trifluridine/tipiracil was approved in the third-line treatment of advanced colorectal cancer. Its efficacy in the first-line treatment was unknown.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. Receives: Drug: Trifluridine/Tipiracil |
| control group | No intervention | The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the rate of patients with PR and CR
Measured: 48 months
Secondary outcomes (2)
PFS
The time from the beginning of randomization to the time when the disease progresses or the patient dies from any cause.
Measured: 48 months
OS
The time from the beginning of randomization to the time when the patient dies from any cause.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-line TreatmentStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 184 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Ba, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077839
- Sponsor's protocol ID
- TJMUCH-GI-CRC03
- Acronym
- TOBACO
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 25 Oct 2021
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer (TOBACO): a Randomized, Controlled, Phase II Study
- ClinicalTrials.gov ID
- NCT05077839
- Acronym / sponsor ID
- TOBACO / TJMUCH-GI-CRC03
- Conditions
- First-line Treatment, Advanced Colorectal Cancer
- Keywords
- Trifluridine/tipiracil, first-line treatment, advanced colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Oct 2021 (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 two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital.
Patients with advanced colorectal cancer will be randomly assigned (1:1) to trifluridine/tipiracil combined with oxaliplatin and bevacizumab (experimental group) or XELOX plus bevacizumab (control group) after signing informed consent. In this study, 184 patients will be enrolled, 92 patients will receive trifluridine/tipiracil combined with oxaliplatin and bevacizumab and 92 patients will receive standard therapy.
In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. Patients enrolled in this group could acquire trifluridine/tipiracil free of charge.
The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment.
Patients received regular and periodic reviews, with imaging evaluations every 8 weeks. Safety will be evaluated by AE and laboratory tests. All patients were followed up every 3 months until death according to the plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Trifluridine/TipiracilIn the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. |
| control group | No intervention | –The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed the informed consent.
- Age ≥18.
- Colonic adenocarcinoma confirmed histologically or histopathologically.
- No previous chemotherapy for advanced colorectal cancer, or patients who had received adjuvant chemotherapy after radical resection and relapsed 12 months after the completion of adjuvant chemotherapy.
- ECOG physical status score is 0 or 1.
Key exclusion criteria (17 listed)
- Has a serious illness or medical condition, including but not limited to the following:
- Any of the following treatments were received within a specific time frame before the study drug was taken:
- Presence of neurotoxicity of CTCAE grade 2 or above caused by adjuvant therapy.
- Pregnant or lactating women.
- The researcher did not consider it appropriate to enter the 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 |
|---|---|---|
| Trifluridine/TipiracilAlso: TAS-102Trifluridine/tipiracil was approved in the third-line treatment of advanced colorectal cancer. Its efficacy in the first-line treatment was unknown. | Drug | experimental group |
Primary outcome
ORR
Time frame: 48 months
the rate of patients with PR and CR
2 secondary outcomes
PFS
Time frame: 48 months
OS
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- 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.
Yi Ba, MD principal investigator
Tianjin Medical University Cancer Institute and 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 Trifluridine/Tipiracil in people with First-line Treatment and Advanced Colorectal Cancer, run by Tianjin Medical University Cancer Institute and 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 16 inclusion and 17 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 25 Oct 2021. 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 Yi Ba, MD (022-23340123 ext. 1053, bayi@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 48 months). 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 25 Oct 2021.