Actively Recruiting
Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-03-18
45
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
R
Renmin Hospital of Wuhan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.
CONDITIONS
Official Title
Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate
- Age between 18 and 75 years, male or female
- Confirmed diagnosis of locally advanced rectal adenocarcinoma
- High-risk features on pelvic MRI including clinical tumor stage cT4a/b, extramural vascular infiltration, clinical lymph node stage cN2, mesenteric fascia involvement, or enlarged lateral lymph nodes
- Tumor located no more than 10 cm from the anal verge
- Ability to swallow tablets and capsules normally
- ECOG performance status of 0 or 1
- No prior anti-tumor treatment for rectal cancer
- Planned surgery after completing total neoadjuvant therapy
- No contraindications to surgery
- Normal major organ function including specific blood counts and liver, kidney, and coagulation parameters
- Left ventricular ejection fraction of 50% or higher
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and for 6 months after the trial; male participants with partners of childbearing potential must also use effective contraception during and for 6 months after the trial
You will not qualify if you...
- Allergy to anti-angiogenesis drugs, monoclonal antibodies, capecitabine, oxaliplatin, or platinum drugs
- Use of immunosuppressive drugs or systemic hormones for immunosuppression within 2 weeks before treatment
- Received live attenuated vaccine within 4 weeks before treatment
- Major surgery or severe trauma within 4 weeks before treatment
- Active autoimmune disease or history of autoimmune diseases
- History of immunodeficiency or organ/bone marrow transplantation
- Uncontrolled cardiac conditions including heart failure above NYHA class II, recent myocardial infarction, unstable angina, arrhythmias, or poorly controlled hypertension
- Severe infection within 4 weeks before treatment
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection
- Presence of a second primary malignancy
- Pregnant or breastfeeding women
- History of arterial or venous thrombosis within 6 months
- History of psychotropic drug abuse or mental disorders
- Any history or presence of bleeding or high risk of bleeding
- Significant proteinuria confirmed by urine tests
- Other serious diseases or conditions that may affect safety or compliance 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
Wuhan, China
Actively Recruiting
Research Team
Z
zhenyu Lin, Ph.D
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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