Actively Recruiting
Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-31
45
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
CONDITIONS
Official Title
Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years, of any gender
- Histopathologically confirmed locally advanced rectal adenocarcinoma
- Not suitable for or have refused standard therapy due to toxicity, lack of standard therapy, or personal choice
- Hematologic parameters within specified ranges including hemoglobin ≥90 g/L, ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, eosinophils ≤1.5×ULN
- Serum biochemical tests within specified limits including bilirubin ≤1.5×ULN (direct bilirubin ≤ULN if total bilirubin higher), AST/ALT ≤3×ULN, creatinine ≤1.5×ULN or creatinine clearance ≥45 mL/min, albumin ≥30 g/L
- Coagulation tests within specified limits: INR ≤1.5×ULN (≤3×ULN if on stable anticoagulant), PTT/aPTT ≤1.5×ULN (≤3×ULN if on stable anticoagulant)
- Urinalysis showing urine protein <2+ or 24-hour urinary protein <1 g
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Women of childbearing potential and male participants with female partners agree to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Not diagnosed with locally advanced rectal adenocarcinoma
- Previous immunotherapy including immune checkpoint inhibitors or treatments targeting tumor immune mechanisms
- Pregnant or breastfeeding women, or planning pregnancy during treatment or up to 6 months after
- History of active epilepsy, central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Significant cardiovascular disease
- History of allergic constitution, asthma, or atopic dermatitis
- Large pleural effusion or ascites
- Active autoimmune disease requiring systemic treatment within 2 years
- History of allogeneic organ or hematopoietic stem cell transplantation
- Allergy to the study drug or its components
- History of severe toxicities from prior immune checkpoint inhibitors or certain agents requiring treatment discontinuation
- Unresolved toxicity > Grade 1 from prior anticancer therapy (excluding persistent alopecia Grade 2, peripheral neuropathy, anemia, or hypomagnesemia)
- Active uncontrolled bleeding or bleeding disorders, serious non-healing wounds, or portal hypertension with high bleeding risk
- History of bowel obstruction or gastrointestinal perforation risk within 28 days prior to first dose
- Major gastrointestinal diseases within 6 months including significant bleeding, active ulcers, or Grade ≥2 diarrhea within 2 weeks
- Recent cancer treatments within 28 days or traditional Chinese medicine with anticancer effects within 14 days prior to dosing
- Positive HIV, active hepatitis B or C, tuberculosis, or history of these infections
- Serious or uncontrolled infection or fever >38°C within 2 weeks prior to first dose
- Diagnosis of another malignancy within 5 years except certain treated skin cancers and localized prostate or thyroid cancers
- Radiotherapy within 3 months prior to study (palliative radiotherapy allowed if >2 weeks before dosing)
- Any condition or history that may jeopardize safety or compliance or interfere with study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
Actively Recruiting
Research Team
T
tao Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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