Lynch SyndromePhase 3NCT04711434
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
A Phase 3 study testing PD-1 Antibody in people with Lynch Syndrome, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to explore the role of PD-1 Antibody in preventing adenomatous polyps and second primary tumors in patients with Lynch Syndrome. There two arms, one is the experimental arm (PD-1 antibody prevention group) and the other is the control arm (routine follow-up group). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- PD-1 Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2025
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lynch syndrome with germline variants of MLH1, MSH2, or EPCAM (pathogenic or likely pathogenic variants)
- Necessary treatments have been done, such as surgery, chemotherapy, radiation therapy, etc.
- Have a resection, including right hemicolectomy, left hemicolectomy, sigmoid colectomy, or anterior resection of rectal cancer, or endoscopic adenoma resection
- Aged 18-70 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- White blood cell (WBC) > 4000/mm3, Platelet count >100000/mm3, HB >10 g/dL
- Serum glutamic-oxaloacetic transaminase (SGOT) < 1.5 × the upper limit of normal (ULN), Serum glutamic pyruvic transaminase (SGPT) < 1.5 × ULN prior to randomization, Total bilirubin (TBIL) < 1.5 mg/dL
- Serum creatinine (Scr) <1.8 mg/dL
Who cannot join
- Lynch syndrome with germline variants of MSH6 and PMS2
- Previous immunotherapy has been taken, such as anti-PD-1, anti-PD-L1, etc.
- Long-term use of aspirin
- Suffering from autoimmune diseases
- Active infection with hepatitis B or hepatitis C (high copy number of viral DNA) or human immunodeficiency virus (HIV)
- Other clinically serious active infections (NCI-CTC 4.0)
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- With cachexia or organ dysfunction
- Suffering from seizures requiring treatment (such as steroids or antiepileptic therapy)
- Unable to participate or complete the study due to substance abuse, or medical, psychological, or social disorder
- Known allergy to any drugs in this study
- Pregnant or nursing women, or women of childbearing potential who are not using adequate contraception
- Any unstable condition or situation that could compromise the safety and compliance of participants.
- Failure to sign an informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, 510060
Peirong Ding, MD, Ph D, 00862087343124, dingpr@sysucc.org.cn
About this study
Official title: PD-1 Antibody for the Prevention of Adenomatous Polyps and Second Primary Tumors in Patients With Lynch Syndrome: An Open-label, Multicenter, Randomized Controlled Clinical Trial
This study aims to explore the role of PD-1 Antibody in preventing adenomatous polyps and second primary tumors in patients with Lynch Syndrome. There two arms, one is the experimental arm (PD-1 antibody prevention group) and the other is the control arm (routine follow-up group). For the experimental group, Tripleitriumab (PD-1 antibody) is given every 3 months for a year.
Read the detailed description
Lynch syndrome (LS) is a hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of all CRC. LS significantly increases the risk for an individual to develop CRC during their lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers, including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract, CNS, and certain types of skin cancer. Given the hereditary nature of this syndrome, preventing second primary tumors in patients with Lynch Syndrome after surgery to the primary site is very important.
The purpose of this study is to prevent adenomatous polyps and second primary tumors using PD-1 antibody (Tripleitriumab) in patients with Lynch Syndrome.
The primary outcome of this study is the incidence of intestinal adenomatous polyps and secondary primary tumors. The secondary outcomes are the incidence of colorectal adenomatous polyps greater than 1cm, incidence of high-grade colorectal polyps, treatment-related adverse events, disease-free Survival and overall Survival.
There are two groups: the PD-1 antibody prevention group and the routine follow-up group. For the PD-1 antibody prevention group, participants will receive Toripalimab 240mg IV every 3 months for a year. For the routine follow-up group, there is no drug intervention.
This whole study will take 5 years: the first year for recruiting and the latter four years for follow-up.
- Conditions
- Lynch Syndrome
- Being tested
- PD-1 Antibody
- Keywords
- Toripalimab, Lynch Syndrome, Prevention
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 AntibodyDrug
Also called Toripalimab
Toripalimab: 240mg IV every 3 months for a year
| Study group | Role | What they receive |
|---|---|---|
| Prevention group | Experimental | Toripalimab: 240mg IV every 3 months for a year Receives: Drug: PD-1 Antibody |
| Follow-up group | No intervention | Routine follow-up, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors
Measured: up to 5 years
Secondary outcomes (6)
The percentage of patients developing polyps greater than 1cm within 5 years from randomization
Measured: up to 5 years
The percentage of patients developing high-grade polyps on pathology within 5 years from randomization.
Measured: up to 5 years
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
Measured: up to 5 years
Effectiveness with different genotypes or phenotypes
Estimated the percentage of patients with different genotypes or phenotypes not developing polyps or second primary tumors within 5 years from randomization.
Measured: up to 5 years
Disease-free Survival
defined as the time from randomization to the first appearance of one of the following: primary tumor recurrence, or death without cancer event; or censored at date of last follow-up
Measured: up to 5 years
Overall Survival
defined as the time from randomization to death from any cause. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2023 (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 Lynch SyndromeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Kunming Medical College.
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
- Investigators
- Peirong Ding, MD, Ph D, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711434
- Sponsor's protocol ID
- B2020-059-01
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody for the Prevention of Adenomatous Polyps and Second Primary Tumors in Patients With Lynch Syndrome: An Open-label, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04711434
- Acronym / sponsor ID
- B2020-059-01
- Conditions
- Lynch Syndrome
- Keywords
- Toripalimab, Lynch Syndrome, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Kunming Medical College.
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jan 2021 (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.
This study aims to explore the role of PD-1 Antibody in preventing adenomatous polyps and second primary tumors in patients with Lynch Syndrome. There two arms, one is the experimental arm (PD-1 antibody prevention group) and the other is the control arm (routine follow-up group). For the experimental group, Tripleitriumab (PD-1 antibody) is given every 3 months for a year.
Detailed description
Lynch syndrome (LS) is a hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of all CRC. LS significantly increases the risk for an individual to develop CRC during their lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers, including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract, CNS, and certain types of skin cancer. Given the hereditary nature of this syndrome, preventing second primary tumors in patients with Lynch Syndrome after surgery to the primary site is very important.
The purpose of this study is to prevent adenomatous polyps and second primary tumors using PD-1 antibody (Tripleitriumab) in patients with Lynch Syndrome.
The primary outcome of this study is the incidence of intestinal adenomatous polyps and secondary primary tumors. The secondary outcomes are the incidence of colorectal adenomatous polyps greater than 1cm, incidence of high-grade colorectal polyps, treatment-related adverse events, disease-free Survival and overall Survival.
There are two groups: the PD-1 antibody prevention group and the routine follow-up group. For the PD-1 antibody prevention group, participants will receive Toripalimab 240mg IV every 3 months for a year. For the routine follow-up group, there is no drug intervention.
This whole study will take 5 years: the first year for recruiting and the latter four years for follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention group | Experimental | Drug: PD-1 AntibodyToripalimab: 240mg IV every 3 months for a year |
| Follow-up group | No intervention | –Routine follow-up, no intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Lynch syndrome with germline variants of MLH1, MSH2, or EPCAM (pathogenic or likely pathogenic variants)
- Necessary treatments have been done, such as surgery, chemotherapy, radiation therapy, etc.
- Have a resection, including right hemicolectomy, left hemicolectomy, sigmoid colectomy, or anterior resection of rectal cancer, or endoscopic adenoma resection
- Aged 18-70 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
Key exclusion criteria (13 listed)
- Lynch syndrome with germline variants of MSH6 and PMS2
- Previous immunotherapy has been taken, such as anti-PD-1, anti-PD-L1, etc.
- Long-term use of aspirin
- Suffering from autoimmune diseases
- Active infection with hepatitis B or hepatitis C (high copy number of viral DNA) or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| PD-1 AntibodyAlso: ToripalimabToripalimab: 240mg IV every 3 months for a year | Drug | Prevention group |
Primary outcome
The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors
Time frame: up to 5 years
6 secondary outcomes
The percentage of patients developing polyps greater than 1cm within 5 years from randomization
Time frame: up to 5 years
The percentage of patients developing high-grade polyps on pathology within 5 years from randomization.
Time frame: up to 5 years
Treatment-related adverse events
Time frame: up to 5 years
Effectiveness with different genotypes or phenotypes
Time frame: up to 5 years
Disease-free Survival
Time frame: up to 5 years
Overall Survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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.
Peirong Ding, MD, Ph D study chair
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 3 study testing PD-1 Antibody in people with Lynch Syndrome, 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 8 inclusion and 13 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 20 Jan 2021. 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 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 Peirong Ding, MD, Ph D (00862087343124, dingpr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors (time frame: up to 5 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 20 Jan 2021.