DMMR Colorectal CancerPhase 2NCT06262581
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
A Phase 2 study testing Tisleizumab(BGB-A317) in people with DMMR Colorectal Cancer and Anti PD-1, run by Sun Yat-sen University at 1 site in China.
Trial summary
According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DMMR Colorectal Cancer, Anti PD-1, Immunotherapy
- What is being tested?
- Tisleizumab(BGB-A317)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2023to 31 Dec 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
- Able to provide consents and agree to follow the trial requirement and assessment;
- Age >=18
- ECOG score: 0 or1
- Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required)
- Measurable and assessible primary tumor sites according to RECIST 1.1
- Able to provide 22ml peripheral blood for assessment for ctDNA
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- With all organ function sufficient
- No bowel obstruction or fistula
- No previous chemotherapy, radiotherapy and immunotherapy accepted history
- Distant metastasis excluded before surgery by CT scan
- Contraception required for women for the whole enrollment time until 3 months after last dose of immunotherapy
Who cannot join
- self-autoimmune diseases history such as SLE
- People who using the immune suppressor
- Severe allergy to other mono-clone antibody
- Cerebral metastasis which hasn't be managed yet
- Hypertension(SBP>140mmHg，DBP>90mmHg)
- Uncontrolled diabetes(FBG>10mmol/L)
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- Accepted anti-PD-1 or anti-PD-L1 immunotherapy in the past
- Uncontrolled heart diseases such as NYHA II heart failure, unstable angina , cardiac infarction in 1 year and arrhythmia
- Systemic inflammation which needs whole body treatment
- Urine routine: protein >=++ or 24hr urine protein>=1g
- Innate or acquired immune deficiency like HIV and HBV
- Enrolled in other clinical trial already
- Confirmed as metastasis before the surgery
- Other malignancies has been diagnosed before
- Tuberculosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Gong C Chen, Prof, +862087343584, chengong@sysucc.org.cn
Zhi-zhong Pan, Prof
About this study
Official title: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage Colorectal Cancer Patients
According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients.
- Conditions
- DMMR Colorectal Cancer, Anti PD-1, Immunotherapy
- Being tested
- Tisleizumab(BGB-A317)
- Keywords
- CRC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisleizumab(BGB-A317)Drug
Also called surgery
200mg i.v. q3w
| Study group | Role | What they receive |
|---|---|---|
| dMMR/MSI-H stage I-III CRC patients | Experimental | Patients will accept 4 dose of Tisleizumab(BGB-A317) treatment after enrollment and the assessment of the therapeutic effect by clinicians would be finished after that. Once the patients has been qualified as cCR , they could be exempted for surgery and continued the watch and wait management. If the patient has been assessed as able to R0 surgery , then they would received surgery. Otherwise ,they would be excluded from the trial. Receives: Drug: Tisleizumab(BGB-A317) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete regression rate
Patients without noninvasive or focal-invasive residues or involved lymph nodes should be considered as having achieved pCR. The rate is these patients over the whole group.
Measured: From enrollment to 1 year after surgery
Secondary outcomes (3)
CR rate
Patients with non-invasive or focal-invasive or involved lymph nodes which persists for 4 weeks after neoadjuvant immunotherapy. The rate of these patients over the whole group.
Measured: From enrollment to 1 year after surgery
Major Pathological Response rate
Rate of the patients who had focal invasive and residue tumor site which less than 10% both in primary tumors and all lymph nodes.
Measured: From enrollment to 1 year after surgery
Disease free survival
The time interval between the enrollment to the events such as relapse, distant metastasis and progressed occured.
Measured: From enrollment to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start23 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMMR Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Chen, Sun Yat-sen University
- Investigators
- Gong Chen, Prof, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262581
- Sponsor's protocol ID
- 2021-FXY-471
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06262581
- Acronym / sponsor ID
- 2021-FXY-471
- Conditions
- DMMR Colorectal Cancer, Anti PD-1, Immunotherapy
- Keywords
- CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2024 (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.
According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dMMR/MSI-H stage I-III CRC patients | Experimental | Drug: Tisleizumab(BGB-A317)Patients will accept 4 dose of Tisleizumab(BGB-A317) treatment after enrollment and the assessment of the therapeutic effect by clinicians would be finished after that. Once the patients has been qualified as cCR , they could be exempted for surgery and continued the watch and wait management. If the patient has been assessed as able to R0 surgery , then they would received surgery. Otherwise ,they would be excluded from the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to provide consents and agree to follow the trial requirement and assessment;
- Age >=18
- ECOG score: 0 or1
- Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required)
- Measurable and assessible primary tumor sites according to RECIST 1.1
Key exclusion criteria (16 listed)
- self-autoimmune diseases history such as SLE
- People who using the immune suppressor
- Severe allergy to other mono-clone antibody
- Cerebral metastasis which hasn't be managed yet
- Hypertension(SBP>140mmHg，DBP>90mmHg)
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 |
|---|---|---|
| Tisleizumab(BGB-A317)Also: surgery200mg i.v. q3w | Drug | dMMR/MSI-H stage I-III CRC patients |
Primary outcome
pathological complete regression rate
Time frame: From enrollment to 1 year after surgery
Patients without noninvasive or focal-invasive residues or involved lymph nodes should be considered as having achieved pCR. The rate is these patients over the whole group.
3 secondary outcomes
CR rate
Time frame: From enrollment to 1 year after surgery
Major Pathological Response rate
Time frame: From enrollment to 1 year after surgery
Disease free survival
Time frame: From enrollment to 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Gong Chen, Prof principal investigator
Sun Yat-sen University
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 Tisleizumab(BGB-A317) in people with DMMR Colorectal Cancer and Anti PD-1, run by Sun Yat-sen University 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 11 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 16 Feb 2024. 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 Gong Chen, Prof (+86 020 87343584, chengong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete regression rate (time frame: From enrollment to 1 year after surgery). 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 16 Feb 2024.