Clinical trial NCT06184841: HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma
Official title: Hepatic Arterial Infusion Chemotherapy Combined Sintilimab for Predominant Liver Metastasis From Esophageal Squamous Cell Carcinoma- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Arterial Infusion Chemotherapy
Liver Metastases
Esophageal Squamous Cell Carcinoma
Keywords: hepatic arterial infusion chemotherapy
liver metastasis
esophagus carcinoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Innovent Biologics (Suzhou) Co. Ltd.
First posted: 2023-12-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 2 years
Secondary outcomes:
measure: The response rate of liver metastases
timeFrame: Up to 2 years
measure: The overall response rate ( ORR)
timeFrame: Up to 2 years
measure: The time to response (TTR)
timeFrame: Up to 2 years
measure: The duration of response (DOR)
timeFrame: Up to 2 years
measure: The progression free survival (PFS)
timeFrame: Up to 2 years
measure: The overall survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: