Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer

NCT06765616 | Recruiting Phase 2

• 1 other identifier: 23-OBU-SD-CRC-II-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 \* 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 \* 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.

Conditions

Rectal Cancer; Advanced Stage Colorectal Cancer; Radiotherapy

Keywords

Immune checkpoint inhibitors；Adebrelimab Injection

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission rate (pCR)

  Pathological complete remission rate (pCR)

  From enrollment to the end of surgery,assessed up to 6 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  The evaluation time from enrollment to the first efficacy evaluation is up to 3 months

• Major Pathological Response Rate (MPR)

  From enrollment to the end of surgery,assessed up to 6 months

• R0 resection rate

  From enrollment to the end of surgery,assessed up to 6 months

• Adverse reaction incidence rate

  From enrollment to 90 days after the last medication

Study Arms (1)

Adebrelimab Injection combined with radiotherapy and chemotherapy

EXPERIMENTAL

Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1\~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later.

Drug: Adebrelimab Injection combined with radiotherapy and chemotherapy

Interventions

Adebrelimab Injection combined with radiotherapy and chemotherapy DRUG

Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1\~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later.

Adebrelimab Injection combined with radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent before implementing any experimental procedures;
• Male or female, aged 18 or above and 85 or below;
• Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;
• Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (\>5mm) who are determined to be operable and require neoadjuvant therapy through imaging and colonoscopy examination.
• According to imaging and colonoscopy examination, the main body of the patient's tumor is located ≤ 15cm away from the anal edge;
• According to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), there should be at least one measurable lesion on imaging;
• The patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc;
• ECOG score 0-1 points;
• Adequate organ function, subjects must meet the following laboratory indicators:
• In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was ≥ 1.5x109/L.
• Platelets ≥ 100 × 109/L without blood transfusion in the past 14 days.
• Hemoglobin\>9g/dL in the past 14 days without blood transfusion or use of erythropoietin;
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
• Aspartate transaminase (AST) and alanine transaminase (ALT) levels are ≤ 2.5 × ULN
• Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Gault formula) ≥ 60 ml/min;

You may not qualify if:

• Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection);
• Late stage rectal cancer patients with distant metastasis;
• Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration;
• Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
• Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
• Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments;
• Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy;Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used;
• Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Those who are known to be allergic to the active ingredients or excipients of the investigational drug Adabelimab and combination chemotherapy drugs;
• Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);Note: hepatitis B patients who meet the following criteria can also be included in the group:
• Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation
• For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary
• Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);

Sponsors & Collaborators

• Feng Tian: lead

Study Sites (1)

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Changqing Jing, Professor

  Shandong Provincial Hospital

  STUDY DIRECTOR

Central Study Contacts

Feng Tian, Dr.

CONTACT

+86 18866102886; tianfeng@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)