Postoperated colorectal carcinoma liver metastasis
Conditions
Interventions
Treatment Group:On the foundation of TOMO radiotherapy, patients will receive adjuvant adoptive transfer of vNKT cells. For liver metastases (solitary or multiple), stereotactic body radiation therapy
Sponsors
The Fourth People's Hospital of Zibo City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, ECOG performance status 0-1 or KPS>= 70, and an expected survival of >= 6 months. 2. Pathologically confirmed colorectal adenocarcinoma with liver metastasis after failure of first-line therapy. 3. Phenotype of protein and gene testing is pMMR/MSS. The status of RAS/BRAF must be recorded (both wild-type and mutant are allowed). 4. Number of liver metastases = 1.5×10^9/L, PLT >= 75×10^9/L, Hb >= 90 g/L. Renal function: eGFR >= 60 mL/min/1.73m². 8. No active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus), and no long-term use of immunosuppressive agents. 9. No history of severe allergies or prior immune therapy-related toxicities. 10. Willing to sign the informed consent form and able to comply with treatment and regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrolled brain metastases or extensive peritoneal metastases (bone metastases and pulmonary metastases amenable to radiotherapy are allowed). 2. Liver function classified as Child-Pugh grade B or C. 3. Patients with dMMR/MSI-H tumors. 4. Patients with active HIV infection. 5. History of immunotherapy within the past 6 months, including other adoptive cellular immunotherapies (e.g., NK cell therapy). 6. Receipt of chemotherapy or major surgery within 1 month, or palliative radiotherapy within 2 weeks prior to enrollment. 7. Comorbidities: (1)Cardiopulmonary conditions: NYHA Class III–IV heart failure or COPD GOLD stage 3–4. (2)Gastrointestinal risks: Active gastrointestinal bleeding, or risk of bowel obstruction or perforation. 8. Other exclusions: (1)Pregnancy/lactation: Pregnant or breastfeeding women. (2)History of malignancy: Concurrent malignancies other than non-melanoma skin cancer or carcinoma in situ. (3)Inability to comply with treatment or provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-Free Survival;Local Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactWang Fanghan
The Fourth People's Hospital of Zibo City
Outcome results
None listed