Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
NCT ID: NCT06884670
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2025-03-18
2027-07-10
Brief Summary
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Detailed Description
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In recent years, substantial advancements have reshaped the landscape of CRC treatment, offering new hope and improved outcomes for affected individuals. Surgical intervention remains the cornerstone of curative therapy, guided by tumor stage, location, and patient's overall health status. Adjuvant therapies, including chemotherapy and radiotherapy, have been pivotal in reducing recurrence rates and enhancing overall survival. Targeted treatments, such as anti-EGFR and anti-VEGF drugs, have ushered in an era of precision medicine, selectively targeting critical molecular pathways. Meanwhile, immunotherapy, particularly immune checkpoint inhibitors, has emerged as a promising frontier, offering personalized treatment options for CRC patients.
In CRC, the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion; however, the response to PD-1 monotherapy is limited in a majority of colorectal cancer patients, suggesting that combining PD-1 blockade with other immunostimulatory agents holds promise. Currently, several combination therapies have shown progress in animal models and are being explored in clinical studies. Among these, interleukin-2 (IL-2) emerges as a candidate drug, synergizing with PD-1 blockade to potentiate antitumor effects. This study aims to investigate the combination of IL-2 with PD-1 inhibitors, seeking to overcome the limitations of single-agent immunotherapy through multifaceted immunomodulation. By modulating the immune microenvironment to enhance immune cell infiltration and break down the physical and immunosuppressive barriers of the tumor, this approach seeks to augment the efficacy of immunotherapy, particularly for immunologically cold CRC patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Neoadjuvant Group
Radiotherapy 1.8Gy per time\*28 And Capecitabine: 825mg/m2 bid po, a total of 28 days CapeOX 2 cycles (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1
Radiotherapy
Radiotherapy 1.8Gy per time\*28
Oxaliplatin
Oxaliplatin 200 mg/m² ivd, d1
Capecitabine
Capecitabine: 825mg/m2 bid po, d1-d14
PD-1+IL-2+CapeOX group
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (total 6 cycles)
Interleukin-2
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1)
Tislelizumab
Tislelizumab 200mg ivd D1
Oxaliplatin
Oxaliplatin 200 mg/m² ivd, d1
Capecitabine
Capecitabine: 825mg/m2 bid po, d1-d14
Interventions
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Interleukin-2
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1)
Radiotherapy
Radiotherapy 1.8Gy per time\*28
Tislelizumab
Tislelizumab 200mg ivd D1
Oxaliplatin
Oxaliplatin 200 mg/m² ivd, d1
Capecitabine
Capecitabine: 825mg/m2 bid po, d1-d14
Eligibility Criteria
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Inclusion Criteria
2. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
3. Histologically confirmed rectal adenocarcinoma;
4. Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
5. Microsatellite stable (MSS) status;
6. Adequate hematological, hepatic, and renal functions.
Exclusion Criteria
2. Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
3. Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
4. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
5. Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
6. Pregnant or breastfeeding women.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Locations
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Nanjing BenQ Hospital
Nanjing, Jiangsu, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Xuzhou Central hospital
Xuzhou, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PICM
Identifier Type: -
Identifier Source: org_study_id
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