HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

Prior treatment

• lung, bone, mediastinal lymph nodes, multiple lower abdominal lymph nodes, pelvic lymph nodes and other distant metastases, unable to receive local radiotherapy.
• 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.
• patients had received previous immunotherapy, such as PD-1 antibody, PD-L1 antibody, CTLA4 antibody.
• 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.

Other illness

• History of esophagogastric bleeding, hepatic encephalopathy, massive ascites, and abdominal infection.
• allergic to Sintilimab.

Lab values

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

Age

• age \> 75 years old;

Other

• ECOG score ≥2;

• Both male and female, aged 18-75 years;
• ECOG score 0-1;
• Pathological diagnosis: metastatic esophageal squamous cell carcinoma confirmed by histological or cytological examination (excluding adenosquamous carcinoma mixed type and other pathological types).
• 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
• predicted survival time ≥3 months.
• 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).
• HBV infection, should have effective antiviral treatment, HBV DNA \< 100IU/ml.
• agree to be enrolled in the study, be willing to cooperate with the clinical research, and sign the informed consent.
• 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.