Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor DNA | — | UNRESOLVED | — |
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| circulating tumor DNA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Traditional neoadjuvant chemoradiotherapy group
- description
- Eligible patients randomized into arm A will receive traditional neoadjuvant chemoradiotherapy, including long-course radiotherapy with a total number of 45-50.4Gy in 25-28 fractions, and with concurrent 3 times of oral capecitabine, the strategies of capecitabine are: During radiotherapy: capecitabine 1650mg/m2/d, orally administered twice a day, d1-d14, every 3 weeks as a course; During the non-radiotherapy period: capecitabine 2000mg/m2/d, orally administered twice daily, d1-d14, every 3 weeks as a course
- type
- EXPERIMENTAL
- label
- ctDNA-guided neoadjuvant treatment group
- description
- After sequencing tumor tissue, those with MSI-H/TMB-H or POLD/POLE2 mutation willed be arranged to receive immune therapy following NCRT，Terelizumab，200mg. The others are arranged to randomly receive TNT (VAF\>0.4%) or NCRT (VAF\<0.4%) according to VAF value by the level of ctDNA. TNT： Long course radiotherapy combined with 2 courses of single-agent capecitabine chemotherapy → 6 courses of CapeOX (Capecitabine 2000mg/m2/ day, twice orally, d1-14; Oxaliplatin 100-130mg/m2, intravenous infusion, d1; Every 3 weeks for a course of treatment.) chemotherapy was performed 2 to 3 weeks after the end of chemotherapy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75 years; 2. ECOG score 0-2; 3. Rectal adenocarcinoma confirmed by pathology; 4. The lower margin of the tumor was less than 12cm from the anal margin; 5. Patients with clinical stage cT3-4N0M0 or cTanyN+M0; 6. Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery; 7. Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery; 8. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent. Exclusion Criteria: 1. ECOG score \> 2; 2. Patients with multiple primary colorectal cancers; 3. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years; 4. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; 5. pregnant or lactating women; 6. Patients with a history of severe mental illness, immune disease, hormone medication; 7. Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery; 8. Participated in other clinical researchers in the past 3 months; 9. Any other circumstances that the investigator considers inappropriate for inclusion.
References
Publications (2)
- DERIVEDZhang X, Zhou J, Geng J, Li Y, Huang F, Shu W, Fu W, Zhou X, Wu G, Jia W, Cui J, Wang Z, Han J, Shi B, Li L, Rui J, Xue H, Hu K, Xu T, Chen W, Lu J, Yao H, Liu Q, Lin G. Feasibility of ctDNA-guided precision neoadjuvant therapy in locally advanced rectal cancer: Insights from the ongoing CINTS-R trial. Eur J Cancer. 2026 Feb 5;234:116193. doi: 10.1016/j.ejca.2025.116193. Epub 2025 Dec 18. PMID 41435753
- DERIVEDZhou J, Zhang X, Liu Q, Li Y, Wu G, Fu W, Yao H, Wang Z, Xue H, Xu T, Chen W, Lu J, Zhang G, Wu B, An Y, Qiu X, Xiao Y, Lin G. Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R). BMJ Open. 2025 Feb 2;15(1):e090765. doi: 10.1136/bmjopen-2024-090765. PMID 39894522