HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

NCT ID: NCT06184841

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2023-12-01

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).

Conditions

Hepatic Arterial Infusion Chemotherapy; Liver Metastases; Esophageal Squamous Cell Carcinoma

Keywords

hepatic arterial infusion chemotherapy; liver metastasis; esophagus carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

esophageal squamous cell carcinoma with liver metastasis

Patients with esophageal squamous cell carcinoma with liver metastasis have poor response to first-line treatment, especially those with advanced esophageal cancer with progression or recurrence in the liver.

Group Type: EXPERIMENTAL

HAIC combined with intravenous PD-1

Intervention Type: DRUG

Hepatic arterial chemoinfusion (HAIC) was used for interventional therapy with at least 2 cycles of hepatic arterial infusion. The intervention was started with sintilimab at the same time, 200mg each time, and the drug was repeated every 3 weeks.

Interventions

HAIC combined with intravenous PD-1

Hepatic arterial chemoinfusion (HAIC) was used for interventional therapy with at least 2 cycles of hepatic arterial infusion. The intervention was started with sintilimab at the same time, 200mg each time, and the drug was repeated every 3 weeks.

Intervention Type: DRUG

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.

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.

Exclusion Criteria

1. age > 75 years old;

2. ECOG score ≥2;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Guang Cao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HAIC FOR LMESC

Identifier Type: -

Identifier Source: org_study_id