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NCT06599827

PHASE2

Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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）

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-20

Completion Date

2029-09-20

Last Updated

2024-09-19

Healthy Volunteers

Conditions

Rectal Cancer

Interventions

RADIATION

moderately hypofractionated radiotherapy

35 Gy in 10 fractions to mesorectal and metastatic lymph nodes, and 30 Gy in 10 fractions to pelvic lymphatic drainage area, weekly over 5 days at 3-3.5 Gy/day.

DRUG

chemotherapy

CapeOx-Capecitabine 1000 mg/m² orally twice daily (days 1-14, every 21 days) + Oxaliplatin 130 mg/m² IV (day 1, every 21 days).

DRUG

immunotherapy

Serplulimab 300 mg IV infusion on day 1 every 21 days.

PROCEDURE

Total mesorectal excision (TME) surgery

Total mesorectal excision (TME) surgery assessment post 3 cycles of chemotherapy and immunotherapy; eligible patients undergo TME surgery.

Inclusion Criteria: 1. Age ≥18 and ≤75 years. 2. MRI-confirmed rectal adenocarcinoma with the lower edge of the lesion ≤10cm from the anal verge. 3. Immunohistochemistry confirms proficiency in DNA mismatch repair (pMMR), or genetic testing confirms microsatellite instability-low (MSI-L) or microsatellite stable (MSS) status. 4. 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. 5. ECOG performance status of 0-1. 6. No prior surgery, radiotherapy, chemotherapy, or targeted therapy. 7. Tolerable to radiotherapy, chemotherapy, and immunotherapy with laboratory results: WBC ≥4.0 × 10\^9/L, platelets ≥100 × 10\^9/L, hemoglobin ≥80g/L, ALT \&lt;2ULN, TB \&lt;35μmol/L, Scr \&lt;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). 8. Voluntary participation with signed informed consent. Exclusion Criteria: 1. Distant metastases. 2. Stage I or II rectal cancer not requiring neoadjuvant therapy. 3. Severe cardiovascular, pulmonary, neurological, renal, gastrointestinal, or systemic diseases. 4. Untreated chronic hepatitis B carrier with HBV DNA \&gt;500 IU/ml, HCV RNA positive patients, except for inactive hepatitis B surface antigen carriers, stable hepatitis B (HBV DNA \&lt;500 IU/ml), and cured hepatitis C patients. 5. History of active autoimmune diseases or potential relapse of autoimmune diseases. 6. Patients who received corticosteroids (equivalent to prednisone \&gt;10mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration. 7. History of thyroid dysfunction. 8. Severe chronic or active infections requiring systemic antifungal or antiviral therapy, including tuberculosis. 9. Known allergy or hypersensitivity to multiple drugs. 10. History of pelvic radiation. 11. History of inflammatory bowel disease. 12. Unwillingness to participate or sign informed consent.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China