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NCT05601505: CINTS-R
Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
Phase 2 trial testing circulating tumor DNA in Locally Advanced Rectal Carcinoma in 470 participants. Currently enrolling.
31 October 2025
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 470 |
| Start date | 3 February 2023 |
| Primary completion | 31 October 2025 |
| Estimated completion | 1 November 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- circulating tumor DNA
Conditions studied
- Locally Advanced Rectal Carcinoma — all drugs for Locally Advanced Rectal Carcinoma →
- Circulating Tumor DNA — all drugs for Circulating Tumor DNA →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05601505
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of circulating tumor DNA
Trials testing the same drug.
- NCT06157060 — Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA · recruiting
Other recruiting trials for Locally Advanced Rectal Carcinoma
Currently open trials in the same condition.
- NCT07372300 — Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07038122 — Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cance · NA · active not recruiting
- NCT06276686 — Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer · EARLY_PHASE1 · recruiting
- NCT06312982 — A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer · Phase 2, PHASE3 · recruiting
- NCT05731726 — Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer · Phase 2 · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
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- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05601505 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
- Last refreshed: 24 December 2024
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