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NCT05601505: CINTS-R

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

Recruiting now Phase 2 Last updated 24 December 2024
What this trial tests

Phase 2 trial testing circulating tumor DNA in Locally Advanced Rectal Carcinoma in 470 participants. Currently enrolling.

Timeline
3 February 2023
Primary endpoint
31 October 2025
1 November 2026

Quick facts

Lead sponsorPeking Union Medical College Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment470
Start date3 February 2023
Primary completion31 October 2025
Estimated completion1 November 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 75, any sex, with Locally Advanced Rectal Carcinoma or Circulating Tumor DNA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Position of Circulating Tumor DNA in the Clinical Management of Colorectal Cancer.
    de Abreu AR, Op de Beeck K, Laurent-Puig P, Taly V, et al · · 2023 · cited 14× · PMID 36831626 · DOI 10.3390/cancers15041284
  2. Circulating tumor DNA for MRD detection in colorectal cancer: recent advances and clinical implications.
    Ma D, Gao X, Wang L, Yin H, et al · · 2025 · cited 8× · PMID 40551262 · DOI 10.1186/s40364-025-00796-w
  3. Assessing circulating tumour DNA (ctDNA) as a prognostic biomarker in locally advanced rectal cancer: a systematic review and meta-analysis.
    O'Sullivan NJ, Temperley HC, Kyle ET, Sweeney KJ, et al · · 2024 · cited 8× · PMID 38809315 · DOI 10.1007/s00384-024-04656-1
  4. Circulating tumour DNA in predicting and monitoring survival of patients with locally advanced rectal cancer undergoing multimodal treatment: long-term results from a prospective multicenter study.
    Zhou J, Li L, Liu Y, Jia W, et al · · 2025 · cited 6× · PMID 39818166 · DOI 10.1016/j.ebiom.2024.105548
  5. A Review of Circulating Tumor DNA as a Biomarker Guide for Total Neoadjuvant Therapy in Patients with Locally Advanced Rectal Cancer.
    Yahya J, Baber M, Nabavizadeh N, Goodyear SM, et al · · 2023 · cited 5× · PMID 36719559 · DOI 10.1007/s12029-022-00906-z
  6. Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R).
    Zhou J, Zhang X, Liu Q, Li Y, et al · · 2025 · cited 4× · PMID 39894522 · DOI 10.1136/bmjopen-2024-090765
  7. Circulating tumor DNA in colorectal cancer: biology, methods and applications.
    Chen H, An Y, Wang C, Zhou J. · · 2025 · cited 2× · PMID 40167831 · DOI 10.1007/s12672-025-02220-z
  8. The Method of Minimal Residual Disease Detection With Circulating Tumor DNA and Its Clinical Applications in Colorectal Cancer.
    Liu M, Mu T, Gu J, Xu M, et al · · 2025 · cited 2× · PMID 40033897 · DOI 10.1002/cnr2.70167

Verify or expand the search:

Other trials of circulating tumor DNA

Trials testing the same drug.

Other recruiting trials for Locally Advanced Rectal Carcinoma

Currently open trials in the same condition.

Other Peking Union Medical College Hospital trials

Trials by the same sponsor.

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