Clinical trial · Interventional
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence: A Randomized Controlled Phase II Trial
- 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 is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.
Conditions
Conditions (4)
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 |
| Immunotherapy | — | UNRESOLVED | — |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| PD-1 antibody | Drug | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- chemotherapy with radiotherapy and immunotherapy
- description
- radiotherapy: SBRT of liver lesions; postoperative chemotherapy and immunotherapy: chemotherapy by investigators' choice with sintilimab for 18 weeks
- interventionNames
- Radiation: SBRT
- Drug: Chemotherapy
- Drug: PD-1 antibody
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- postoperative chemotherapy: chemotherapy by investigators' choice for 18 weeks
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 18 years old, female and male 2. pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous) 3. Metastatic liver lesions \<= 5 4. Primary colorectal cancer under control 5. Absence of evidence of extra-hepatic diseases 6. Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection 7. Karnofsky \>= 70 8. Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy 9. Without previous antitumoral immunotherapy 10. With good compliance 11. Signed the inform consent Exclusion Criteria: 1. Pregnancy or breast-feeding women 2. History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ) 3. History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders 4. Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents 6. Severe uncontrolled recurrent infections 7. Baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN 8. Allergic to any component of the therapy
References
Publications (0)
Data not yet available