HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

NCT06184841 | Completed Phase 1

• 1 other identifier: HAIC FOR LMESC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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

  Up to 2 years

Secondary Outcomes (6)

• The response rate of liver metastases

  Up to 2 years

• The overall response rate ( ORR)

  Up to 2 years

• The time to response (TTR)

  Up to 2 years

• The duration of response (DOR)

  Up to 2 years

• The progression free survival (PFS)

  Up to 2 years

Study Arms (1)

esophageal squamous cell carcinoma with liver metastasis

EXPERIMENTAL

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.

Drug: HAIC combined with intravenous PD-1

Interventions

HAIC combined with intravenous PD-1 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.

esophageal squamous cell carcinoma with liver metastasis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age \> 75 years old;
• ECOG score ≥2;
• History of esophagogastric bleeding, hepatic encephalopathy, massive ascites, and abdominal infection.
• 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.
• allergic to Sintilimab.
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: December 28, 2023
• Study Start: June 18, 2020
• Primary Completion: October 18, 2023
• Study Completion: December 1, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CN (1)