HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with liver metastasis from esophagus squamous (ESC) are usually offered systemic therapy. However, for those with predominant liver disease or failure of system therapy, local liver management becomes an option. This prospective single center study aimed to evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC) using percutaneous catheter placement techniques for liver metastases from esophagus squamous (ESC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Cancer Hospital & Institute
• Collaborator: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

1. Both male and female, aged 18-75 years;

2. ECOG score 0-1;

3. Pathological diagnosis: metastatic esophageal squamous cell carcinoma confirmed by histological or cytological examination (excluding adenosquamous carcinoma mixed type and other pathological types).

4. Metachronous liver metastasis after esophagectomy, especially when liver was the only metastatic organ, or synchronous liver metastasis progressed after first-line medical treatment; Or liver metastasis is currently the main threat, and control of liver metastasis should be the main goal

5. predicted survival time ≥3 months.

6. Liver function: Child-Pugh score 5-7. ALT, AST, ALP< 2.5 times upper limit of normal, total bilirubin< 1.5 times upper limit of normal, PT, INR were < 1.5 times upper limit of normal, respectively. Bone marrow function was good (white blood cell ≥3.0 x 109/L, granulocyte ≥1.5 x 109/L, platelet ≥75 x 109/L, HGB≥100g/l), renal function was good (BUN < 40mg/dl, creatinine < 2mg/ml).

7. HBV infection, should have effective antiviral treatment, HBV DNA < 100IU/ml.

8. agree to be enrolled in the study, be willing to cooperate with the clinical research, and sign the informed consent.

9. Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should use effective contraception during the entire treatment period and for 6 months after the treatment period.

Exclusion Criteria:

1. age > 75 years old;

2. ECOG score ≥2;

3. poor liver function, Child-Pugh score > 7, or liver enzyme, coagulation, bilirubin and bone marrow function did not meet the inclusion criteria.

4. History of esophagogastric bleeding, hepatic encephalopathy, massive ascites, and abdominal infection.

5. lung, bone, mediastinal lymph nodes, multiple lower abdominal lymph nodes, pelvic lymph nodes and other distant metastases, unable to receive local radiotherapy.

6. The tumor was close to the intestinal tract and other organs, and it was difficult to tolerate interventional therapy; Patients with residual liver volume less than 800ml and difficult to tolerate interventional therapy.

7. allergic to Sintilimab.

8. patients had received previous immunotherapy, such as PD-1 antibody, PD-L1 antibody, CTLA4 antibody.

9. use of immunosuppressive drugs within the previous 4 weeks, excluding intranasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/ day of prednisone or the equivalent dose of other glucocorticoids), and temporary use of glucocorticoids for the treatment of dyspnea in conditions such as asthma, chronic obstructive pulmonary disease, etc.