NCT05601505 Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
| NCT ID | NCT05601505 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Locally Advanced Rectal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 470 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 470 participants in total. It began in 2023-02-03 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05601505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Rectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05601505 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05601505 currently recruiting?
Yes, NCT05601505 is actively recruiting participants. Contact the research team at linguole@126.com for enrollment information.
Where is the NCT05601505 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05601505 clinical trial?
NCT05601505 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 470 participants.