Clinical trial · Observational
Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases
Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases: A Single-Center, Single-Arm, Open-Label Clinical Study (PRICE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study attempts to employ a combination therapy using rhG-CSF, IL-2, and PD-1 inhibitors, aiming to overcome the limitations of monotherapy in immunotherapy through multi-faceted immune regulation. By modulating the immune microenvironment to enhance immune cell infiltration, and breaking through the physical and immunosuppressive barriers of tumors, it seeks to augment the efficacy of immunotherapy. This approach explores the effectiveness of a neoadjuvant treatment model in cases of liver metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
| Neupogen | Drug | Filgrastim | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- CapeOX+PD-1+IL-2+rhG-CSF
- description
- Tislelizumab 200mg ivd D1 + Interleukin 2 100IU HD,QOD d1-d14+rhG-CSF 5mcg/kg HD, QD d1-d14 +CapeOX (Capecitabine: 1000mg/m2 bid po, d1-d14;Oxaliplatin 130mg/m2 ivd, d1) 6 cycles
- interventionNames
- Drug: Tislelizumab
- Drug: Interleukin-2
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Neupogen
Primary outcomes (1)
- measure
- CR rate (cCR + local excision pCR)
- timeFrame
- 3 years
- description
- Complete Response rate," which includes both "complete clinical response" (cCR)
Secondary outcomes (2)
- measure
- Event-Free Survival rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years and ≤75 years 2. Histologically confirmed colorectal adenocarcinoma 3. pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable) 4. Synchronous liver metastases 5. Achievable NED (No Evidence of Disease) status 6. CRS (Clinical Risk Score) of 3-4 points 7. ECOG (Eastern Cooperative Oncology Group) Performance Status score ≤ 1 Exclusion Criteria: 1. Recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies. 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.
References
Publications (0)
Data not yet available