Clinical trial · Interventional
Evaluation of The Efficacy And Safety of PD-1 + IL-2 Combined With Capox Treatment After Loop Colostomy Surgery in Left-sided Colorectal Cancer Patients Complicating Acute Obstruction
Evaluation of The Efficacy And Safety of Tislelizumab (PD-1) Monoclonal Antibody + IL-2 Combined With Capox Treatment Following Loop Colostomy Surgery in Left-sided Colorectal Cancer Patients Complicating Acute Obstruction
NCT06394791CI-TRIAL-00076622unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluation of The Efficacy And Safety of Tislelizumab (PD-1) Monoclonal Antibody + IL-2 Combined with Capox Treatment Following Loop Colostomy Surgery in Left-sided Colorectal Cancer Patients Complicating Acute Obstruction
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 |
|---|---|---|---|
| Left-sided Colorectal Cancer Complicating Acute Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab + IL-2 Combined with Capox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Tislelizumab with Interleukin-2+CAPOX
- interventionNames
- Drug: Tislelizumab + IL-2 Combined with Capox
Primary outcomes (1)
- measure
- Clinical Objective Response Rate (CORR)
- timeFrame
- 18 weeks
- description
- To assess whether neoadjuvant Tislelizumab (PD-1) monoclonal antibody + Interleukin-2 (IL-2) combined with Capox can achieve tumor downstaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females aged between 40 and 75 years; * ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1; * Tumor tissue samples obtained and histologically confirmed as colon or rectal adenocarcinoma; * Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10\^9/L; platelet count ≥ 75×10\^9/L; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL. Exclusion Criteria: * Metastatic disease (Stage IV); * Recurrent colorectal cancer; * Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone; * Previous systemic anti-cancer treatment for colorectal cancer; * Coexistence of other non-colorectal cancer malignancies; * Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs; * Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia); * Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation); * Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies; * Pregnant or breastfeeding women; * Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); * Known or suspected allergy history to any drugs used in the trial; * Pregnant or breastfeeding women.
References
Publications (0)
Data not yet available
No reference posted for this study.