Search / Trial NCT06613165

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

Launched by XIJING HOSPITAL · Sep 23, 2024

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Trial Information

Current as of December 30, 2024

Recruiting

Keywords

Colorectal Cancer Deficient Mismatch Repair Locally Advanced Immune Checkpoint

ClinConnect Summary

This clinical trial is investigating the best length of treatment using a special type of immunotherapy called PD-1 monotherapy for patients with a specific type of rectal cancer known as dMMR/MSI-H. The goal is to determine the minimum number of treatment cycles needed to achieve a complete response before surgery, while ensuring that patients respond well to the treatment. Participants will receive this therapy before surgery and will be closely monitored every couple of cycles to see if they are responding well enough to proceed to surgery.

To be eligible for the trial, participants must be between 18 and 80 years old, have a confirmed diagnosis of stage II-III dMMR/MSI-H rectal cancer, and have not received any previous treatments like chemotherapy or radiation. They should also be in relatively good health with normal organ function. If you or a loved one is considering participation, you can expect regular check-ups to assess how well the treatment is working and monitor any side effects. The trial is currently recruiting participants, and those who join will be contributing to important research that could improve treatment options for rectal cancer patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 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.
  • Exclusion Criteria:
  • • 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;
  • • 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.

About Xijing Hospital

Xijing Hospital, a prominent medical institution affiliated with the Fourth Military Medical University in Xi'an, China, is dedicated to advancing healthcare through innovative clinical research. Renowned for its comprehensive range of medical services and expertise in various specialties, Xijing Hospital actively sponsors clinical trials aimed at evaluating new therapies, improving patient outcomes, and contributing to scientific knowledge. With a commitment to ethical standards and patient safety, the hospital fosters collaboration among multidisciplinary teams to drive forward the development of effective treatment options that address critical health challenges.

Locations

Xi'an, Shaanxi, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0