RecruitingPhase 2NCT05601505

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer --- a Multicenter Randomized Controlled Trial (CINTS-R)

Sponsor

Peking Union Medical College Hospital

Enrollment

470 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Circulating Tumor DNA Locally Advanced Rectal Carcinoma

Summary

Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study uses circulating tumor DNA (tiny fragments of cancer DNA found in the blood) to guide how rectal cancer is treated before surgery. By testing the blood, doctors hope to tailor the treatment intensity to each patient's specific cancer behavior, using chemotherapy and radiation before surgery. **You may be eligible if...** - You are age 18 to 75 - You have been diagnosed with rectal adenocarcinoma (a type of rectal cancer) confirmed by biopsy - Your tumor is within 12 cm of the anal margin - Your cancer is at a locally advanced stage (Stage T3-4 or lymph node positive, with no distant spread) - You have not yet received any treatment for this cancer - Your organs (liver, kidneys) are functioning adequately **You may NOT be eligible if...** - Your cancer has spread to distant organs (e.g., the liver or lungs) - You have had prior treatment for this rectal cancer - You have serious health conditions that would make chemotherapy or radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERcirculating tumor DNA

This study will further testify the prognostic value of ctDNA in the treatment term of locally advanced rectal cancer, the higher the VAF value, the higher the risk of recurrence and metastasis.

Locations(1)

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,

Beijing, Beijing Municipality, China

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NCT05601505

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