HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

Phase 1

Completed

• Conditions: Liver Metastases; Hepatic Arterial Infusion Chemotherapy; Esophageal Squamous Cell Carcinoma
• Interventions: Drug: HAIC combined with intravenous PD-1

• Registration Number: NCT06184841
• Lead Sponsor: Peking University Cancer Hospital & Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-18
• Study First Submitted: 2023-01-03
• Primary Completion: 2023-10-18
• Status Verified: 2023-12
• Study Completion: 2023-12-01
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
esophageal squamous cell carcinoma with liver metastasis	HAIC combined with intravenous PD-1	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 2 years	Defined as the proportion of patients with Adverse events (AEs), Treatment Emergent Adverse events (TEAEs), Treatment-related AEs (TRAEs), immune-related AEs (irAEs), adverse events of special interest (AESI) and Serious Adverse events (SAE), assessed by NCI CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
The response rate of liver metastases	Up to 2 years	Defined as proportion of patients who have a best response of CR or PR of liver metastases
The time to response (TTR)	Up to 2 years	Defined as the time between the date of treatment start and objective tumor response
The overall survival (OS)	Up to 2 years	Defined as the time from the date of treatment start to the date of death
The overall response rate ( ORR)	Up to 2 years	Defined as proportion of patients who have a best response of CR or PR
The duration of response (DOR)	Up to 2 years	Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
The progression free survival (PFS)	Up to 2 years	Defined as the time from the date of treatment start to disease progression, or death due to any cause, whichever occurs first.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China