Actively Recruiting
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
Led by Huazhong University of Science and Technology · Updated on 2024-07-24
33
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy
CONDITIONS
Official Title
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent to participate in the study
- Aged between 18 and 75 years, male or female
- Histologically confirmed proficient mismatch repair/microsatellite stable rectal adenocarcinoma
- Tumor's lower margin is 10 cm or less from the anal verge
- Clinical stage T3NanyM0 with specified imaging features, or T4NanyM0
- Expected to achieve complete tumor removal (R0 resection)
- Able to swallow tablets normally
- ECOG performance status of 0 or 1 at enrollment
- No previous anti-tumor therapy for rectal cancer
- Planning to have surgery after neoadjuvant therapy
- No contraindications for surgery
- Normal major organ function with specified blood and biochemistry values
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and for 3 months after the study; males with partners of childbearing potential must also use effective contraception during and for 3 months after the study
You will not qualify if you...
- Allergy to monoclonal antibodies or any components of camrelizumab, fluzoparib, capecitabine, oxaliplatin, or other platinum-based drugs
- Prior radiotherapy, chemotherapy, or other antitumor drugs for the tumor
- Recent use of immunosuppressive or systemic hormonal drugs above specified doses within 2 weeks before study drug
- Live attenuated vaccine within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Active or history of autoimmune diseases requiring intervention
- History of immunodeficiency, including HIV or organ/bone marrow transplant
- Uncontrolled cardiac conditions such as heart failure, unstable angina, recent myocardial infarction, or arrhythmias
- Serious infection within 4 weeks before study drug
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- Other cancers diagnosed within 5 years except low-risk treated skin or cervical cancers
- Pregnant or breastfeeding women
- Other serious illnesses, psychiatric conditions, alcoholism, drug abuse, or social factors affecting safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
X
Xianglin Yuan
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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