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Hepatic Arterial Infusion ChemotherapyPhase 1NCT06184841

HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma

A Phase 1 study testing HAIC combined with intravenous PD-1 in people with Hepatic Arterial Infusion Chemotherapy and Liver Metastases, run by Peking University Cancer Hospital & Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HAIC combined with intravenous PD-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
18 Jun 2020to 1 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • age > 75 years old;
  • ECOG score ≥2;
  • poor liver function, Child-Pugh score > 7, or liver enzyme, coagulation, bilirubin and bone marrow function did not meet the inclusion criteria.
  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Hepatic Arterial Infusion Chemotherapy Combined Sintilimab for Predominant Liver Metastasis From Esophageal Squamous Cell Carcinoma- A Pilot Study

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).

Being tested
HAIC combined with intravenous PD-1
Keywords
hepatic arterial infusion chemotherapy, liver metastasis, esophagus carcinoma
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAIC combined with intravenous PD-1Drug

    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.

Study groups in NCT06184841
Study groupRoleWhat they receive
esophageal squamous cell carcinoma with liver metastasisExperimentalPatients 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.
Receives: Drug: HAIC combined with intravenous PD-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 2 years

Secondary outcomes (6)

  1. The response rate of liver metastases

    Defined as proportion of patients who have a best response of CR or PR of liver metastases

    Measured: Up to 2 years

  2. The overall response rate ( ORR)

    Defined as proportion of patients who have a best response of CR or PR

    Measured: Up to 2 years

  3. The time to response (TTR)

    Defined as the time between the date of treatment start and objective tumor response

    Measured: Up to 2 years

  4. The duration of response (DOR)

    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.

    Measured: Up to 2 years

  5. The progression free survival (PFS)

    Defined as the time from the date of treatment start to disease progression, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  6. The overall survival (OS)

    Defined as the time from the date of treatment start to the date of death

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2023
  2. Study start18 Jun 2020
  3. Primary completion18 Oct 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06184841
Sponsor's protocol ID
HAIC FOR LMESC
Status last verified
Dec 2023
First submitted
3 Jan 2023
Last updated
28 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HAIC combined with intravenous PD-1 in people with Hepatic Arterial Infusion Chemotherapy and Liver Metastases, run by Peking University Cancer Hospital & Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06184841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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