NCT06599827Not yet recruitingPhase 2
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk PMMR/MSS Locally Advanced Rectal Cancer: a Prospective, Exploratory Phase II Trial（iMHRT-LARC）
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate the effectiveness and safety of combining moderately hypofractionated radiotherapy with chemotherapy and anti-PD-1 antibodies as a neoadjuvant treatment for high-risk locally advanced rectal cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 5 Sept 2024
- Start date
- 20 Sept 2024
- Primary completion date
- 20 Sept 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06599827
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From 20 Sept 2024 to the primary completion date, 20 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received corticosteroids (equivalent to prednisone \>10mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration.
Other illness
- Stage I or II rectal cancer not requiring neoadjuvant therapy.
- Severe cardiovascular, pulmonary, neurological, renal, gastrointestinal, or systemic diseases.
- Untreated chronic hepatitis B carrier with HBV DNA \>500 IU/ml, HCV RNA positive patients, except for inactive hepatitis B surface antigen carriers, stable hepatitis B (HBV DNA \<500 IU/ml), and cured hepatitis C patients.
- History of active autoimmune diseases or potential relapse of autoimmune diseases.
- History of thyroid dysfunction.
- Severe chronic or active infections requiring systemic antifungal or antiviral therapy, including tuberculosis.
- Known allergy or hypersensitivity to multiple drugs.
- History of pelvic radiation.
- History of inflammatory bowel disease.
Other
- Distant metastases.
- Unwillingness to participate or sign informed consent.
Who the study is looking for
- Age ≥18 and ≤75 years.
- MRI-confirmed rectal adenocarcinoma with the lower edge of the lesion ≤10cm from the anal verge.
- Immunohistochemistry confirms proficiency in DNA mismatch repair (pMMR), or genetic testing confirms microsatellite instability-low (MSI-L) or microsatellite stable (MSS) status.
- Pelvic MRI showing one of the following high-risk factors: cT4a/b; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph nodes.
- ECOG performance status of 0-1.
- No prior surgery, radiotherapy, chemotherapy, or targeted therapy.
- Tolerable to radiotherapy, chemotherapy, and immunotherapy with laboratory results: WBC ≥4.0 × 10\^9/L, platelets ≥100 × 10\^9/L, hemoglobin ≥80g/L, ALT \<2ULN, TB \<35μmol/L, Scr \<1.5ULN or creatinine clearance rate ≥50mL/min, TSH ≤ULN (if abnormal, consider T3 and T4 levels; if T3 and T4 are normal, patients can still be included).
- Voluntary participation with signed informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.