Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer

NCT05086627 | Completed Phase 2

• 1 other identifier: 2021104
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.

Conditions

Locally Advanced Rectal Cancer

Keywords

Locally advanced rectal cancer; Neoadjuvant radiotherapy; Immune checkpoint inhibitors; Programmed death-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)

  1 week after surgery

Secondary Outcomes (4)

• major pathologic response (TRG0+TRG1)

  1 week after surgery

• 3-year PFS

  3 years from randomization

• 3-year OS

  3 years from randomization

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 1 year

Study Arms (2)

Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

EXPERIMENTAL

Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.

Drug: Tislelizumab; Radiation: Short-course radiotherapy; Drug: Capecitabine+Oxaliplatin

Short-course radiotherapy sequential CapeOX (group B)

ACTIVE COMPARATOR

Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.

Radiation: Short-course radiotherapy; Drug: Capecitabine+Oxaliplatin

Interventions

Tislelizumab DRUG

Patients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin).

Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

Short-course radiotherapy RADIATION

Patients were treated with short-course neoadjuvant radiotherapy

Short-course radiotherapy sequential CapeOX (group B); Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

Capecitabine+Oxaliplatin DRUG

Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).

Short-course radiotherapy sequential CapeOX (group B); Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their family members agree to participate in the study and sign the informed consent form;
• Patients ≥ 18 and ≤75 years old, male or female;
• ECOG performance status of 0 or 1;
• Patients with histologically confirmed rectal adenocarcinoma;
• The clinical diagnosis of chest CT, abdominal and pelvic enhanced MRI was T1-2N+M0 and cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used);
• The distance between the lower edge of the tumor and the anal edge is less than or equal to 10 cm;
• No history of immune system diseases;
• No history of immunodeficiency, including HIV positive;
• No history of other malignancies;
• No history of myocarditis;
• No history of severe cardiovascular and cerebrovascular diseases;
• No history of thyroid dysfunction;
• No history of liver and kidney diseases;
• No history of mental illness, no history of Infectious diseases;
• No history of organ transplantation or allogeneic bone marrow transplantation;

You may not qualify if:

• Documented history of allergy to study drugs, including any component of Tislelizumab, capecitabine, oxaliplatin and other platinum drugs;
• Patients who need to be treated with corticosteroid (dose equivalent to prednisone of \>10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
• Severe infection (CTCAE \> 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
• Female patients who is pregnant or breastfeeding;
• Patients who refuse to sign informed consent by themselves or their authorized persons;
• Patients with poor cognitive ability, unable to answer questions, unable to fill in questionnaires or mental disorders;
• Patients considered unsuitable for the study by the investigator.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Interventions

tislelizumab; XELOX

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 21, 2021
• Study Start: September 1, 2021
• Primary Completion: July 30, 2024
• Study Completion: August 20, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)