Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab,… (NCT07509424) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance
29 participantsStarted 2026-04-22
Plain-language summary
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects voluntarily participate in this study, are able to sign the informed consent form, and demonstrate good compliance.
✓. Subjects are aged between 18 and 75 years (at the time of signing the informed consent form), regardless of gender.
✓. Subjects are diagnosed with locally advanced rectal cancer by histology and/or cytology, with the lower edge of the tumor ≤10 cm from the anal verge. According to the 8th edition of the AJCC criteria, the disease is diagnosed as locally advanced. Based on endoscopic ultrasound or enhanced CT/MRI scans (combined with diagnostic laparoscopic exploration if necessary), the cTNM stage is T3 - 4N+, and the subjects agree to undergo total mesorectal excision.
✓. The tumor is ≤5 cm from the anal verge and the subject has a need for anal - preservation, or pelvic MRI shows high - risk features (meeting one of the following conditions):
Exclusion criteria
✕. Diagnosis of a malignant disease other than colorectal cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
✕. Tumor lesions with a bleeding tendency (e.g., presence of an active ulcerated tumor lesion with a positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, judged by the investigator to be at risk of major gastrointestinal bleeding, etc.) or having received blood transfusion within 4 weeks before the study drug administration.
✕. Inability to take oral medications.
✕. Currently participating in an interventional clinical research treatment, or having received other research drugs or used research devices for treatment within 4 weeks before the first dose.
What they're measuring
1
Complete response (CR) rate
Timeframe: Perioperative
Trial details
NCT IDNCT07509424
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. Previous exposure to the following therapies: anti - HER2, anti - PD - 1, anti - PD - L1, anti - PD - L2 drugs, or drugs targeting another stimulatory or co - inhibitory T - cell receptor (including but not limited to CTLA - 4, OX - 40, CD137, etc.).
✕. Systemic treatment with Chinese patent medicines with anti - tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose.
✕. Occurrence of an active autoimmune disease requiring systemic treatment (e.g., use of disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
✕. Receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Note: Use of physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) is allowed.