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Colorectal CancerPhase 2/3NCT05409417

Exploratory Study on Combined Conversion Immunotherapy for Liver Metastasis of MSS Type Initial Unresectable Colorectal Cancer Based on Gene Status

A Phase 2/3 study testing Experimental drug in people with Colorectal Cancer and Liver Metastases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Evaluation of tislellimab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab regimen in patients with liver metastases from colorectal cancer Rate and R0 resection rate and safety. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer, Liver Metastases
What is being tested?
Experimental drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Oct 2022to 1 Sep 2024
Phase
Phase 2/3
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

  • 3.1 Entry criteria:
  • Male or female, age ≥18 years old, ≤75 years old
  • Liver metastases of colorectal adenocarcinoma confirmed by histology, liver metastases are initially unresectable
  • RAS gene mutation or wild type, BRAF wild type, MSS type
  • ECOG physical status is 0 to 1 points
  • Life expectancy is at least 12 weeks
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  • Absolute neutrophil count (ANC)>1.5×109/L, hemoglobin>8g/dL and platelets>100×109/L (based on the normal value of the clinical trial center)
  • Prothrombin time (PT) <1.5 times the upper limit of normal and normal thromboplastin time (APTT) <1.5 times the upper limit of normal
  • Laboratory examination, serum creatinine is less than or equal to 1.5 times the upper limit of the reference range of normal value (if serum creatinine rises, 24-hour urine must be collected, except for those with 24-hour creatinine clearance> 50ml/min)
  • When there is no liver metastasis, ALT or AST is less than or equal to 2.5 times the upper limit of the normal value reference range, and serum total bilirubin is less than or equal to 1.5 times the upper limit of the normal value reference range; for patients with liver metastases, ALT or AST is less than Or equal to 5 times the upper limit of the reference range of normal values, and serum total bilirubin is less than or equal to 3 times the upper limit of the reference range of normal values
  • Women of childbearing age must be willing to adopt adequate contraceptive measures during study drug treatment
  • Signed informed consent
  • According to the definition of RECIST 1.1, the investigator determines that the patient has a measurable disease. Tumor lesions located in the area of previous radiotherapy are considered measurable if they are confirmed to have progressed.

Who cannot join

  • 3.2 Exclusion criteria:
  • An active autoimmune disease that requires systemic treatment (i.e., use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred in the previous 2 years. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments.
  • Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the experimental treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.
  • Anti-tumor monoclonal antibody (mAb) received within 4 weeks before the first day of the study, or adverse events caused by the drug received 4 weeks before have not yet recovered (ie ≤ grade 1 or reach baseline level).
  • Have received chemotherapy, targeted small molecule therapy or radiotherapy within 2 weeks before the first day of the study, or the adverse events caused by the previously received drugs have not yet recovered (ie ≤ grade 1 or reach the baseline level). Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss are exceptions to this standard and may be eligible to participate in the study. a. If subjects have undergone major surgery, they must fully recover from the toxicity and/or complications caused by the intervention before starting treatment.
  • Other malignant tumors are known to be progressing or requiring active treatment. Exclude skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ that have received radical treatment.
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  • Active central nervous system (CNS) metastasis and/or cancerous meningitis are known to exist. Subjects who have received brain metastasis therapy can also participate in this study, provided that their condition is stable (no disease progression confirmed by imaging examination at least 4 weeks before the first administration of the trial treatment, and all neurological symptoms have returned to Baseline level), there is no evidence that new or enlarged brain metastases have occurred, and steroid therapy should be discontinued at least 7 days before the first dose of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether the clinical condition is stable. Have a history of pneumonia (non-infectious) requiring steroid treatment or are currently suffering from pneumonia (non-infectious).
  • Active infections requiring systemic treatment.
  • It is possible to confuse the test results, prevent the subjects from participating in the research in the whole process of medical history or disease evidence, abnormal treatment or laboratory values, or the researcher believes that participating in the research is not in the subjects' best interests.
  • It is known that there are mental or drug abuse diseases that may affect compliance with the test requirements.
  • During pregnancy or lactation, or expected to be during the planned trial period (from the beginning of the screening visit to 120 days after the last dose of the study treatment (applicable to the Pembrolizumab group), or until 180 days after the last dose of the study treatment ( Applicable to paclitaxel group)) conceived female subjects, or male subjects whose spouse becomes pregnant.
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibody) infection.
  • Known to have active hepatitis B or C. Active hepatitis B is defined as a known positive result of HBsAg and an HBV viral load exceeding 2000 IU/ml (104 copies/ml). Active hepatitis C is defined as a known hepatitis C antibody positive, and the quantitative result of known hepatitis C RNA is higher than the detection limit of the analytical method. Note: HCV RNA (quantitative) and HBsAg testing will be performed during the screening period; if there are results obtained within 3 months before the screening period, it can also be used.
  • Live vaccines have been vaccinated within 30 days before the planned start date of the study treatment. a. Note: Seasonal influenza vaccines for injection are generally inactivated influenza vaccines and are allowed to be used; but intranasal influenza vaccines (such as FluMist®) are live attenuated vaccines and are not allowed.
  • BRAF gene mutation type, MSI-H
  • -

Trial locations and contacts

1 site in 1 country.

Ying Yuan, MD contact

+86-13858193601

yuanying1999@zju.edu.cn

Xuefeng Fang, phD contact

+86-13968037427

xffang@zju.edu.cn

China1 site, 1 recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Ying Yuan, +86-13858193601, yuanying1999@zju.edu.cn

    Recruiting

Other trials in China

About this study

Evaluation of tislellimab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab regimen in patients with liver metastases from colorectal cancer Rate and R0 resection rate and safety.

Being tested
Experimental drug
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Experimental drugDrug

    Also called Tilelizumab combined with chemotherapy

    Tilelizumab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab

Study groups in NCT05409417
Study groupRoleWhat they receive
Tislelizumab Combined With chemotherapyExperimentalTislelizumab Combined With XELOX and Bevacizumab or Tislelizumab Combined With FOLFOX and Cetuximab
Receives: Drug: Experimental drug

What is being measured

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

  1. Conversion rates

    Conversion rates based on RECIST1.1

    Measured: 3 months

  2. R0 resection rate

    R0 resection rate based on RECIST1.1

    Measured: 3 months

  3. Drug Safety

    Drug safety assessed by CTCAE v4.0; Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: 12 months

Secondary outcomes (4)

  1. ORR

    objective response rate based on RECIST1.1

    Measured: 3 months

  2. PFS

    Progression-Free Survival %

    Measured: through study completion，an average of 2 years

  3. OS

    Overall survival %

    Measured: through study completion，an average of 3 years

  4. DCR

    Disease control rate % based on RECIST1.1

    Measured: through study completion，an average of 2 years

Timeline

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

  1. First posted8 Jun 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Sep 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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409417
Sponsor's protocol ID
IR2022058
Status last verified
Jan 2022
First submitted
3 Jan 2022
Last updated
8 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Experimental drug in people with Colorectal Cancer and Liver Metastases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 13 inclusion and 16 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 8 Jun 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Ying Yuan, MD (+86-13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion rates (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT05409417.

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 8 Jun 2022.

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