Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody

Rectal Cancer Clinical Trial

— PMMR/MSS  

Official title:

A Single-arm, Single-center, Prospective Clinical Study of Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody for Neoadjuvant Therapy of PMMR/MSS Type Middle and Low Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06014944
• Other study ID #: CHoicelll
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conduct a single-arm, single-center, prospective clinical study enrolling patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had not received systemic anti-tumor therapy to explore the efficacy and safety of short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. This study has been fully understood and voluntarily signed informed consent ;

2. Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was histologically confirmed as pMMR / MSS type ( according to the detection criteria of the institutional testing center, it can be detected by immunohistochemistry, PCR or NGS ), and was staged as stage II ( T3-4N0 ) or stage III ( T1-4N1-2 ) by MRI and CT.

4.MRI was used to evaluate the middle and low rectal cancer below 10 cm from the anal margin of the tumor ; 5.Patients who were recommended for neoadjuvant therapy after evaluation by the Multidisciplinary Oncology Committee ; 6.ECOG physical condition 0-1 points ; 7.Expected survival = 2 years ; 8.No previous anti-tumor treatment has been received ; the function of vital organs meets the following requirements ( not allowed to use any blood components and cell growth factors within * 14 days before enrollment ) : Absolute neutrophil count = 1.5 × 109 / L ; platelet = 100 × 109 / L ; hemoglobin = 90g / L ; total bilirubin < 1.5 times ULN ; aLT and / or AST < 2.5 times ULN ; serum creatinine < 1.5 times ULN ; endogenous creatinine clearance rate = 50ml / min ; 10. Women of childbearing age need to take effective contraceptive measures ; 11.good compliance, with follow-up.

Exclusion Criteria:

• 1.Unable to comply with the research program or research procedures ; 2.Patients with surgical taboos ; 3.Patients with metastatic disease or recurrent rectal cancer ; 4.Patients with familial adenomatous polyposis ( FAP ), hereditary nonpolyposis colorectal cancer ( HNPCC ), active Crohn 's disease or active ulcerative colitis ; 5.Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ; 6.Severe cardiovascular diseases, including unstable angina or myocardial infarction, occurred within 6 months before enrollment ; 7.Subjects who were allergic to the study drug or any of its adjuvants ; 8.Participated in other domestic unapproved or unlisted drug clinical trials within 4 weeks before enrollment and received corresponding experimental drug treatment ; 9.International normalized ratio ( INR ) > 1.5 or activated partial thromboplastin time ( APTT ) > 1.5 × ULN ; 10.Investigators judged clinically significant electrolyte abnormalities ; 11.There was uncontrolled hypertension before enrollment, which was defined as : systolic blood pressure = 140 mmHg and / or diastolic blood pressure = 90 mmHg ; 12.There were poorly controlled diabetes before enrollment ( after regular treatment, fasting glucose concentration = CTCAE grade 2 ) ; 1.3.13.Before enrollment, there are any diseases or states that affect drug absorption, or patients cannot take oral drugs ; 14.Before entering the group, there were gastrointestinal diseases such as gastric and duodenal active ulcers and ulcerative colitis, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researchers ; 15.Severe active bleeding, hemoptysis ( fresh blood > 5 mL within 4 weeks ) or thromboembolic events occurred within 12 months before enrollment ( package ).

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
neoadjuvant therapy for short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody for PMMR / MSS type middle and low locally advanced rectal cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cCR rate	the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.	5 years