A Study on the Efficacy and Safety of Sintilimab Combined with Bevacizumab in Perioperative Neoadjuvant Chemotherapy for Locally Advanced Low Rectal Cancer

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

This is a prospective, exploratory clinical study. The primary endpoint of the study is to assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab. The aim is to evaluate the efficacy and safety of sintilimab in combination with bevacizumab in the perioperative neoadjuvant chemotherapy for rectal cancer. The study includes two cohorts: Cohort A involves a retrospective collection of rectal cancer patients who previously received the XELOX regimen in the perioperative setting. Cohort B includes rectal cancer patients undergoing perioperative treatment with sintilimab and bevacizumab combined with XELOX as a neoadjuvant regimen. Each of the trial group and historical control group requires 59 cases. The administration method for the trial group (Cohort B) is as follows: Sintilimab: 200 mg, intravenous, Day 1, every 3 weeks. Bevacizumab: 7.5 mg/kg, intravenous, Day 1, every 3 weeks. Chemotherapy regimen: XELOX regimen.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Cohort A:

• Rectal cancer patients who have previously received perioperative XELOX regimen treatment.

• Cohort B:

⁃ Signed written informed consent prior to any trial-related procedures;

⁃ Non-bedridden cases, regardless of gender, aged 18-75 years;

⁃ Pathologically confirmed rectal adenocarcinoma, excluding anal squamous cell carcinoma;

⁃ No prior antitumor treatment for rectal cancer. For those with Lynch syndrome, no antitumor treatment has been administered for the colorectal cancer related to this diagnosis;

⁃ Based on high-resolution MRI, classified as T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the levator ani muscle; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancerous nodules;

⁃ ECOG performance status of 0-1;

⁃ Expected survival time \> 3 months;

⁃ Adequate organ function, with subjects meeting the following laboratory criteria:

⁃ Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L without using granulocyte colony-stimulating factor in the past 14 days.

⁃ Platelet count ≥ 100 x 10\^9/L without transfusion in the past 14 days.

⁃ Hemoglobin \> 9 g/dL without transfusion or use of erythropoietin in the past 14 days;

⁃ Total bilirubin ≤ 1.5 × upper limit of normal (ULN); if total bilirubin \> 1.5 × ULN but direct bilirubin ≤ ULN, enrollment is also allowed;

⁃ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastases are allowed if ALT or AST ≤ 5 × ULN);

⁃ Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 ml/min;

⁃ Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN;

⁃ Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, subjects can still be enrolled if total T3 (or FT3) and FT4 are within normal range;

⁃ Normal levels of cardiac enzyme profile (subjects may still be enrolled if the investigator judges the laboratory abnormality to be of no clinical significance); (optional)

‣ For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of the investigational drug (Day 1 of Cycle 1) with a negative result. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential females are defined as those who have been postmenopausal for at least one year, or have undergone surgical sterilization or hysterectomy;

∙ If there is a risk of conception, all subjects (regardless of gender) must use contraception with a failure rate of less than 1% throughout the treatment period and until 120 days after the last dose of the investigational drug (or 180 days after the last dose of chemotherapy).

Locations
Other Locations
China
Xijing Hospital
RECRUITING
Xi'an
Contact Information
Primary
wang
wangyannian001@qq.com
86-13201793393
Time Frame
Start Date: 2024-07-05
Estimated Completion Date: 2025-06-05
Participants
Target number of participants: 118
Treatments
Experimental: Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvan
Related Therapeutic Areas
Sponsors
Leads: xiaohua li

This content was sourced from clinicaltrials.gov

Similar Clinical Trials