ImmunotherapyPhase 2NCT05314101
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
A Phase 2 study testing Tislelizumab, bevacizumab and TAS-102 in people with Immunotherapy and Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunotherapy, Colorectal Cancer
- What is being tested?
- Tislelizumab, bevacizumab and TAS-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 28 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who provided informed consent and voluntarily enrolled
- Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
- 18-75 years old;
- Measurable target lesions according to RECIST V1.1 assessment criteria;
- Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
- 0 ~ 2 points according to ECOG quality of life score;
Show all 12Show fewer
- Drugs can be taken orally
- Estimated survival ≥3 months;
- Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
- Ascites with no obvious symptoms and no clinical intervention;
- Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
- Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.
Who cannot join
- Previous application of TAS-102;
- Pregnant or lactating women;
- No contraception during the reproductive period;
- patients known to have a history of allergy to any study drug, similar drug or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except those caused by PICC;
Show all 14Show fewer
- Patients with active infection;
- Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);
- Patients with brain metastases with clinical symptoms or imaging evidence;
- Contraindications for treatment of other chronic diseases;
- Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;
- According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;
- Other conditions that the investigator determines are not suitable for inclusion in the study.
- Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FujianCH
Fuzhou, Fujian
Yang jian wei, 13805097959, swzcq62@163.com
About this study
Official title: TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial
To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.
- Conditions
- Immunotherapy, Colorectal Cancer
- Being tested
- Tislelizumab, bevacizumab, TAS-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
bevacizumabDrug
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks
TAS-102Drug
Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 combined with bevacizumab and tislelizumab | Experimental | TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer Receives: Drug: Tislelizumab; Drug: bevacizumab; Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Time from enrollment to the onset of disease progression or death.
Measured: up to 24 months
Secondary outcomes (1)
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: every 8 weeks (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Apr 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Fujian 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314101
- Sponsor's protocol ID
- TBT001
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 23 Aug 2022
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT05314101
- Acronym / sponsor ID
- TBT001
- Conditions
- Immunotherapy, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 6 Apr 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.
To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 combined with bevacizumab and tislelizumab | Experimental | Drug: Tislelizumab, Drug: bevacizumab, Drug: TAS-102TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who provided informed consent and voluntarily enrolled
- Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
- 18-75 years old;
- Measurable target lesions according to RECIST V1.1 assessment criteria;
- Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
Key exclusion criteria (14 listed)
- Previous application of TAS-102;
- Pregnant or lactating women;
- No contraception during the reproductive period;
- patients known to have a history of allergy to any study drug, similar drug or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
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 |
|---|---|---|
| TislelizumabParticipants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks | Drug | TAS-102 combined with bevacizumab and tislelizumab |
| bevacizumabParticipants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks | Drug | TAS-102 combined with bevacizumab and tislelizumab |
| TAS-102Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks | Drug | TAS-102 combined with bevacizumab and tislelizumab |
Primary outcome
progression free survival
Time frame: up to 24 months
Time from enrollment to the onset of disease progression or death.
1 secondary outcome
Objective Response Rate (ORR)
Time frame: every 8 weeks (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Immunotherapy
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
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.
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 Tislelizumab, bevacizumab and TAS-102 in people with Immunotherapy and Colorectal Cancer, run by Fujian 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 12 inclusion and 14 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 23 Aug 2022. 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 Yang jian wei, bachelor (13805097959 ext. 86, swzcq62@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 (time frame: up to 24 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 23 Aug 2022.