Immune-related Adverse EventNCT06613165
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
An observational study of Immune-related Adverse Event and Neoadjuvant Therapy, run by Xijing Hospital at 1 site in China.
Trial summary
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune-related Adverse Event, Neoadjuvant Therapy, dMMR Colorectal Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 20 Sep 2028
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage II-III dMMR rectal cancer
Who may be able to join
- 1.Age: 18 to 80 years old, male or female;
- 2.Patients with histologically or cytologically confirmed dMMR/MSI-H rectal adenocarcinoma, clinical stage II-III;
- 3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
- 4.ECOG Performance Status (PS) score of 0-1;
- 5.Estimated life expectancy of ≥ 3 months;
- 6.Normal function of major organs, with no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency. Laboratory tests must meet the following criteria: Hemoglobin (Hb) ≥ 90 g/L; White blood cell count (WBC) ≥ 3.0 × 10^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 90 × 10^9/L; Liver function (Aspartate Aminotransferase AST or Alanine Aminotransferase ALT) ≤ 2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) ≤ 1.5 times ULN; Total bilirubin (TBIL) ≤ 1.5 times ULN; Urine protein and occult blood < 2+; Fecal occult blood < 2+;
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- 7.Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits;
- 8.The investigator believes that the patient can benefit from the treatment. Physical status score PS ≤ 2;
- 9.Patients and their families must understand and be willing to participate in this study, providing written informed consent.
Who cannot join
- 1.Patients with a confirmed allergy to the investigational drug and/or its excipients;
- 2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- 3.Patients with any active autoimmune disease or a history of autoimmune disease;
- 4.Patients with Lynch syndrome;
- 5.Patients with poorly controlled cardiac symptoms or diseases, such as New York Heart Association (NYHA) Class II or higher heart failure, unstable angina pectoris, or myocardial infarction within the past year;
- 6.Pregnant or lactating women;
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- 7.Patients with acute infections requiring antibiotic treatment;
- 8.Patients with positive hepatitis B or hepatitis C antibodies;
- 9.Patients with positive HIV antibodies;
- 10.Patients with other diseases that the investigating physician considers may affect prognosis and survival;
- 11.Any other conditions deemed inappropriate for participation in this study by the investigating physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi
Jipeng LI, Doctor, +86-029-84771533, jipeng1974@aliyun.com
Yihuan Qiao, Doctor, 18682986362, yhqiao1995@126.com
About this study
Official title: Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective，Multicentre, Single-arm Study
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer.
Participants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved.
Researchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.
- Keywords
- Colorectal Cancer, deficient Mismatch Repair, locally advanced, immune checkpoint
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year event-free survival
Three-year event-free survival (EFS) is a medical metric used in oncology to evaluate the duration over which patients with a particular cancer diagnosis remain free from any cancer-related events, such as disease progression, recurrence, or death from the cancer, within a three-year period following the initiation of treatment.
Measured: 2028.09
Secondary outcomes (1)
Pathological complete response，pCR
Pathological complete response (pCR) is a term used in oncology to describe the absence of any viable tumor cells in the resected tissue specimen following treatment, typically neoadjuvant therapy (such as chemotherapy, radiation therapy, or immunotherapy) prior to surgery.
Measured: 2026.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613165
- Sponsor's protocol ID
- XJ dMMR CRC PD-1
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective，Multicentre, Single-arm Study
- ClinicalTrials.gov ID
- NCT06613165
- Acronym / sponsor ID
- XJ dMMR CRC PD-1
- Keywords
- Colorectal Cancer, deficient Mismatch Repair, locally advanced, immune checkpoint
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 25 Sep 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.
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer.
Participants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved.
Researchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage II-III dMMR rectal cancer
Key inclusion criteria (9 listed)
- 1.Age: 18 to 80 years old, male or female;
- 2.Patients with histologically or cytologically confirmed dMMR/MSI-H rectal adenocarcinoma, clinical stage II-III;
- 3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
- 4.ECOG Performance Status (PS) score of 0-1;
- 5.Estimated life expectancy of ≥ 3 months;
Key exclusion criteria (11 listed)
- 1.Patients with a confirmed allergy to the investigational drug and/or its excipients;
- 2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- 3.Patients with any active autoimmune disease or a history of autoimmune disease;
- 4.Patients with Lynch syndrome;
- 5.Patients with poorly controlled cardiac symptoms or diseases, such as New York Heart Association (NYHA) Class II or higher heart failure, unstable angina pectoris, or myocardial infarction within the past year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Three-year event-free survival
Time frame: 2028.09
Three-year event-free survival (EFS) is a medical metric used in oncology to evaluate the duration over which patients with a particular cancer diagnosis remain free from any cancer-related events, such as disease progression, recurrence, or death from the cancer, within a three-year period following the initiation of treatment.
1 secondary outcome
Pathological complete response，pCR
Time frame: 2026.09
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 27 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-related Adverse Event and Neoadjuvant Therapy, run by Xijing Hospital 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Dec 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.
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?
Contact Jipeng Li, Doctor (Jipeng, jipeng1974@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-year event-free survival (time frame: 2028.09). 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 27 Dec 2024.