Colon CancerPhase 2NCT05231850
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.
A Phase 2 study testing Tislelizumab in people with Colon Cancer, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Sep 2027
- 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
- Male or female subjects aged ≥18 years
- ECOG PS 0/1
- Histologically proven, high-risk stage II (i.e., T3 or T4, N0, M0) and III (i.e., any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection - that is, at least 15 cm from the anal margin).
- Fully surgically resected tumour with clear resection margins (i.e., >1 mm)
- Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6).
- Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins).
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- Absence of metastases as shown by post-operative CT scan.
- No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6.
- Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy 8. Adequate hematological function defined by absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count ≥100 × 109/L, and hemoglobin ≥9 g/dL (blood transfusion before recruitment is allowed)
- Adequate hepatic function defined by a total bilirubin level ≤1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤2.5 × ULN 10. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) 11. Negative serum or urine pregnancy test at screening for women of childbearing potential 12. Fertile men and women must agree to take highly effective contraceptive precautions during, and for 6 months after the last dose of chemotherapy or for 1 month after the last dose of Tislelizumab
Who cannot join
- Rectal tumours (as defined by the presence of the inferior pole of the tumour below the peritoneal reflection - that is, <15 cm from the anal margin).
- Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a history of non-infectious pneumonitis that required steroids; currently active non-infectious pneumonitis; or evidence of interstitial lung disease.
- Has an active infection requiring systemic therapy or history of uncontrolled infection.
- Pregnancy or lactation
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- Known alcohol or drug abuse
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3 NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- Known history of colitis, pneumonitis and pulmonary fibrosis (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment.
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Vaccination within 4 weeks of the first dose of Avelumab and while on trial is prohibited except for administration of inactivated vaccines
About this study
Official title: A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With High-risk Stage Ⅱ and Stage Ⅲ Colon Cancer and Deficient Mismatch Repair or Microsatellite Instability.
10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate. Metastatic dMMR colon cancers are highly sensitive to immune checkpoint inhibition.The MSI phenotype is associated with a better prognosis than MSS in stage II and III CRCs. However, there are conflicting data about the benefit of adjuvant chemotherapy in this group of patients.
We are conducting a single arm study phase II trial to determine if the anti-PD-1 antibody Tislelizumab improves disease-free survival (DFS) in patients with high risk stage II and stage III dMMR/MSI-H colon cancer.
Read the detailed description
This study is a phase II, single arm study with main purpose to evaluate the safety, tolerability and efficacy of Tislelizumab as adjuvant therapy for patients with high-risk stage Ⅱ and stage Ⅲ colon cancer and deficient mismatch repair or microsatellite instability.
Tumour MMR status will be routinely tested locally as per NICE guidelines (either in the pre-operative biopsy or resection specimen). Subjects whose tumours are dMMR can sign the main study consent and undergo the study screening procedures.All eligible patients receive received 200 mg Tislelizumab intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent. The maximum duration of the trial intervention period was 1 year.
- Conditions
- Colon Cancer
- Being tested
- Tislelizumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
All eligible patients receive received 200 mg Tislelizumab intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab | Experimental | Tislelizumab Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary End point: Disease Free survival [ Time Frame: 3 years ]
Disease-free survival (DFS) at 3 years. DFS is measured from the date of randomisation to the date of first relapse (radiological or clinical) or death from any cause.
Measured: 3 years
Secondary outcomes (2)
Overall survival
the time from randomization to death, from any cause
Measured: 5 years
Incidence of adverse events
Incidence of adverse events
Measured: Up to 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231850
- Sponsor's protocol ID
- Wfeng-001
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With High-risk Stage Ⅱ and Stage Ⅲ Colon Cancer and Deficient Mismatch Repair or Microsatellite Instability.
- ClinicalTrials.gov ID
- NCT05231850
- Acronym / sponsor ID
- Wfeng-001
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Feb 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.
10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate. Metastatic dMMR colon cancers are highly sensitive to immune checkpoint inhibition.The MSI phenotype is associated with a better prognosis than MSS in stage II and III CRCs. However, there are conflicting data about the benefit of adjuvant chemotherapy in this group of patients.
We are conducting a single arm study phase II trial to determine if the anti-PD-1 antibody Tislelizumab improves disease-free survival (DFS) in patients with high risk stage II and stage III dMMR/MSI-H colon cancer.
Detailed description
This study is a phase II, single arm study with main purpose to evaluate the safety, tolerability and efficacy of Tislelizumab as adjuvant therapy for patients with high-risk stage Ⅱ and stage Ⅲ colon cancer and deficient mismatch repair or microsatellite instability.
Tumour MMR status will be routinely tested locally as per NICE guidelines (either in the pre-operative biopsy or resection specimen). Subjects whose tumours are dMMR can sign the main study consent and undergo the study screening procedures.All eligible patients receive received 200 mg Tislelizumab intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent. The maximum duration of the trial intervention period was 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab | Experimental | Drug: TislelizumabTislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects aged ≥18 years
- ECOG PS 0/1
- Histologically proven, high-risk stage II (i.e., T3 or T4, N0, M0) and III (i.e., any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection - that is, at least 15 cm from the anal margin).
- Fully surgically resected tumour with clear resection margins (i.e., >1 mm)
- Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6).
Key exclusion criteria (12 listed)
- Rectal tumours (as defined by the presence of the inferior pole of the tumour below the peritoneal reflection - that is, <15 cm from the anal margin).
- Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a history of non-infectious pneumonitis that required steroids; currently active non-infectious pneumonitis; or evidence of interstitial lung disease.
- Has an active infection requiring systemic therapy or history of uncontrolled infection.
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 |
|---|---|---|
| TislelizumabAll eligible patients receive received 200 mg Tislelizumab intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent. | Drug | Tislelizumab |
Primary outcome
Primary End point: Disease Free survival [ Time Frame: 3 years ]
Time frame: 3 years
Disease-free survival (DFS) at 3 years. DFS is measured from the date of randomisation to the date of first relapse (radiological or clinical) or death from any cause.
2 secondary outcomes
Overall survival
Time frame: 5 years
Incidence of adverse events
Time frame: Up to 30 days after last treatment
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 9 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Colon Cancer, run by The First Affiliated Hospital of Zhengzhou University.
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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Primary End point: Disease Free survival [ Time Frame: 3 years ] (time frame: 3 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 9 Feb 2022.