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 (UNION PRECISION-I)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Signed written informed consent and volunteered to participate in the study;

• Age 18-75 years old (including the cut-off value), male or female;

• Locally advanced rectal adenocarcinoma confirmed by histopathology;

• High risk on pelvic MRI \[one of the following criteria\] :

‣ Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition)

⁃ Extramural vascular infiltration

⁃ Clinical lymph node (cN) stage cN2 (according to the AJCC, 8th edition)

⁃ Involvement of the mesenteric fascia

⁃ Enlarged lateral lymph nodes

• The distance between the lower edge of the tumor and the anal edge is ≤10cm;

• Able to swallow tablets and capsules normally;

• ECOG PS 0-1

• Have not received any anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.

• Plan to undergo surgery after completion of total neoadjuvant therapy;

⁃ No surgical contraindications;

⁃ Normal major organ function, including:

• Routine blood test (no blood transfusion and blood products within 14 days prior to the first treatment, no correction with G-CSF and other hematopoietic stimulating factors) :

‣ Neutrophil count ≥ 1.5×109/L

⁃ Platelet count ≥ 100×109/L

⁃ Hemoglobin ≥ 90 g/L

⁃ White blood cell count ≥ 3.0×109/L

∙ Blood biochemical tests:

‣ Total bilirubin ≤ 1.5×ULN (Gilbert's syndrome subjects, ≤3×ULN; Tumor liver metastasis, total bilirubin ≤3×ULN)

⁃ ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN (≤5×ULN for patients with liver metastases)

⁃ Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula, see Annex 2)

∙ Coagulation function:

‣ International Normalized ratio (INR) ≤ 1.5×ULN

⁃ Activated partial thromboplastin time (APTT) ≤ 1.5×ULN

⁃ Prothrombin time (PT) ≤1.5×ULN

∙ Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%

⁃ Female subjects of childbearing potential were required to have a negative serum pregnancy test within 14 days before starting the trial drug and to have used an effective contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the trial and for at least 6 months after the last dose; Male participants whose partner is a woman of childbearing potential should use effective contraception during the trial and for 6 months after the last dose;

Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
zhenyu Lin, Ph.D
whxhlzy@hust.edu.cn
+8615827130393
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 45
Treatments
Experimental: SCRT followed by fruquintinib plus adebrelimab and CAPOX
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: Renmin Hospital of Wuhan University

This content was sourced from clinicaltrials.gov

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