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

Changhai Hospital0 sites30 target enrollmentSeptember 1, 2023

ConditionsRectal Cancer

InterventionsShort-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody

DrugsShort-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody

Overview

Phase: Phase 2
Intervention: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
Conditions: Rectal Cancer
Sponsor: Changhai Hospital
Enrollment: 30
Primary Endpoint: cCR rate
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

December 31, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Changhai Hospital

Responsible Party

Principal Investigator

Wei Zhang

Director of the department of colorectal surgery

Changhai Hospital

Eligibility Criteria

Inclusion Criteria

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

Arms & Interventions

Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody

Radiotherapy 5 \* 5 Gy, once a day, 5 Gy each time, for 5 days.Two weeks after the end of radiotherapy, the patients were treated with furoquintinib combined with slurimab, furoquintinib 5 mg / time / day, d1-14, Q3 W ; combined with 300 mg of brucella, intravenous injection, d1, Q3W ; a total of 4 cycles of treatment.

Intervention: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody

Outcomes

Primary Outcomes

cCR rate

Time Frame: 5 years

the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.