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NCT06613165Recruiting

Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer

Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective,Multicentre, Single-arm Study

Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
23 Sept 2024
Start date
1 Jan 2025
Primary completion date
20 Sept 2026
Lead sponsor
Xijing Hospital
NCT number
NCT06613165

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Jan 2025 to the primary completion date, 20 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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;
  • 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.

Other

  • 6.Pregnant or lactating women;

Who the study is looking for

  • 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+;
  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Xijing hospital
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Xi'anChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.