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Patients With Advanced Metastatic Colorectal CancerPhase 2NCT04924179

Tislelizumab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With Advanced CRC

A Phase 2 study testing Tislelizumab plus Fruquintinib and SBRT in people with Patients With Advanced Metastatic Colorectal Cancer, run by Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase II Study to Assess the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With Advanced Colorectal Cancer Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tislelizumab plus Fruquintinib and SBRT
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 Jun 2021to Jun 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

  • Provision of written Informed Consent Form (ICF) prior to any study specific procedures
  • Age ≥ 18 years, ≤75 years
  • Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
  • One or more organs metastases, and the metastases are suitable for SBRT according to the evaluation of the researchers;
  • At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities
  • ECOG 0-1
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  • Patients must have measurable lesions
  • Expected overall survival ≥12 weeks
  • AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
  • Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
  • Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy
  • Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment

Who cannot join

  • Patients have received anti-PD-1 / PD-L1 immunotherapy or other immunoexperimental drugs
  • Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
  • Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation
  • Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients
  • Aspirin (> 325 mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (≥ 75 mg) and cilostazol are currently used or have been used recently (within 10 days before the start of study treatment)
  • Thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study
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  • The researchers believe that the patient has a lesion and needs emergency palliative radiotherapy / emergency surgery (spinal cord compression, brain hernia, pathological fracture)
  • Known active infection and active tuberculosis infection were not included in the group; However, patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infection can be included in the group if their condition is stable after antiviral treatment;
  • There is evidence of pneumoperitoneum that cannot be explained by puncture or recent surgery;
  • Patients with history of hepatic encephalopathy;
  • Participated in the clinical trials of other drugs that have not been approved or marketed in China and received the corresponding experimental drug treatment within 2 weeks before enrollment
  • systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
  • Patients have untreated central nervous system metastasis
  • Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
  • Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely
  • Dysphagia or known malabsorption of drugs
  • Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI
  • Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment
  • Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Pregnant or lactating women
  • Allergic to Surufatinib/Vinorelbine
  • History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
  • Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis
  • There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher
  • Active autoimmune disease or history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism);
  • Immunosuppressive agents or systemic hormones were used 14 days before the start of the study to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones)
  • Known to have a history of severe allergy to any monoclonal antibody or antiangiogenic target drug
  • Serious psychological or mental disorders that may affect the compliance study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: A Phase II, Single-arm, Open-label, Single Center Study of Tislelizumab Combined With Fruquintinib and SBRT as A Third-line and Posterior Line Treatment in Patients With Advanced Colorectal Cancer

A Phase II Study to Assess the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With Advanced Colorectal Cancer

Being tested
Tislelizumab plus Fruquintinib and SBRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab plus Fruquintinib and SBRTDrug

    Fruquintinib:5mg ,qd,po, d1-d14, 21 days for a cycle;Tislelizumab Injection:200mg，IV,d1,21 days for a cycle;SBRT:8-10Gy×5F,qod,in 10 days.

Study groups in NCT04924179
Study groupRoleWhat they receive
Tislelizumab plus Fruquintinib and SBRTExperimentalNot described
Receives: Drug: Tislelizumab plus Fruquintinib and SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To assess the efficacy of Tislelizumab Combined With Fruquintinib and SBRT for patients with advanced colorectal cancer by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: up to 16 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    CR + PR rate according to the RECIST version 1.1 guidelines.

    Measured: up to 16 months

  2. Disease control rate (DCR)

    Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.

    Measured: up to 16 months

  3. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause)

    Measured: up to 36 months

  4. AEs

    Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04924179
Sponsor's protocol ID
HMPL-013-FLAG-C113
Status last verified
Aug 2022
First submitted
3 Jun 2021
Last updated
17 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab plus Fruquintinib and SBRT in people with Patients With Advanced Metastatic Colorectal Cancer, run by Huazhong University of Science and Technology 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 28 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 17 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924179.

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 17 Aug 2022.

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