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Esophageal Squamous Cell CarcinomasPhase 2NCT05022654

SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.

A Phase 2 study testing SI-B001 and Irinotecan in people with Esophageal Squamous Cell Carcinomas, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multi-center, open label Phase II clinical study is performed in patients with relapsed and metastatic esophageal squamous cell carcinoma progressed on prior PD-1/L1 antibody with or without chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinomas
What is being tested?
SI-B001 and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
6 sitesChina
Study dates
13 Dec 2021to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent and follow the requirements of the protocol;
  • Male or female, age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Locally advanced esophageal squamous cell carcinoma confirmed histologically or pathologically as recurrent or metastatic or without indications of radical local treatment;
  • Patients who failed or were intolerant to first-line anti-PD-1 (L1) monoclonal antibody plus platinum-based chemotherapy
  • Agree to provide archived tumor tissue specimens of primary or metastatic lesion (4 surgical specimens (thickness 5μm) without staining section (anti-removal);6 unstained sections (anti-removal) surgical specimens (thickness 10μm) or fresh tissue samples, if the patient cannot provide, can be included after the investigator's judgment;
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  • There must be at least one measurable lesion conforming to the RECIST V1.1 definition. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion or the lesion persists three months after radiotherapy;
  • Physical fitness ECOG score of 0 or 1;
  • Toxicity from previous antitumor therapy has returned to ≤1 as defined by NCI-CTCAE V5.0 (except for toxicity that the investigators determined to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stabilized hypothyroidism after hormone replacement therapy);
  • Organ function levels must meet the following requirements and meet the following standards:
  • Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours < 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
  • Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial and for at least 6 months after the last medication;Women of childbearing age must have a negative blood or urine pregnancy test within 7 days prior to the first use of the study drug.

Who cannot join

  • Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except for the following:
  • Oral fluorouracil and small molecule targeted drugs were used within 2 weeks before the first administration of the study drug or within 5 half-lives of the drug; The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
  • Patients with esophageal fistula;
  • Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to initial use of the investigational drug;
  • Had major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or had significant trauma within 4 weeks prior to the first use of study drugs, or needed to undergo elective surgery during the trial;
  • Previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
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  • A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc； In the resting state, QT interval was prolonged (QTc > 450 msec in men or QTc > 470 msec in women)； Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration; New York Heart Association (NYHA) heart function grade ≥II heart failure;
  • Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, inflammatory bowel disease, etc., except type I diabetes, hypothyroidism that can be controlled only with replacement therapy, and skin diseases that do not require systemic treatment;
  • Patients with a history of other malignant tumors and signs of recurrence and metastasis within 1 year before the first administration;
  • Poorly controlled hypertension (systolic blood pressure \& GT;150 mmHg or diastolic pressure \&gt;100 mmHg);
  • Pulmonary disease of grade 3 or higher defined by CTCAE V5.0;Patients with past or present interstitial lung disease (ILD);
  • Cerebral parenchymal or meningeal metastases with clinical symptoms were not suitable for inclusion.
  • Previous use of anti-EGFR antibody drug therapy;
  • There are known allergic contraindications to any excipients of SI-B001 or irinotecan;
  • Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, septicemia, etc；'
  • Pregnant or lactating women;
  • Persons with mental disorders or poor compliance;
  • The investigator considers that the subject has a history of other serious systemic diseases or other reasons to be unsuitable for this clinical study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Anyang Cancer Hospital of Henan Province

    Anyang, Henan

  • Beijing Cancer Hostital

    Beijing, Beijing Municipality, 100142

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Suining Central Hospital

    Suining, Sichuan

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

Other trials in China

About this study

Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 Combined With Irinotecan in the Treatment of Recurrent and Metastatic Esophageal Squamous Cell Carcinoma

This multi-center, open label Phase II clinical study is performed in patients with relapsed and metastatic esophageal squamous cell carcinoma progressed on prior PD-1/L1 antibody with or without chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with irinotecan in patients.

Being tested
SI-B001, Irinotecan
Keywords
ESCC

What participants receive

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

  • SI-B001Drug

    Administered by intravenous drip every 2 weeks (Q2W). The first intravenous infusion is 120 min±10min. If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.

  • IrinotecanDrug

    The dose of irinotecan was 180mg/m2 Q2W, the infusion method was according to the drug instructions, SI-B001 and irinotecan were used on the same day, and irinotecan was injected after SI-B001 infusion.

Study groups in NCT05022654
Study groupRoleWhat they receive
SI-B001 combined with irinotecanExperimentalPatients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.
Receives: Drug: SI-B001; Drug: Irinotecan

What is being measured

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

  1. ORR

    objective response rate

    Measured: Up to approximately 24 months

  2. Optimal combination dose (only IIa)

    Optimal combination dose of SI-B001 with irinotecan(only IIa)

    Measured: Up to approximately 24 months

Secondary outcomes (9)

  1. PFS

    Progression-Free-Survival

    Measured: Up to approximately 24 months

  2. DCR

    Disease-control rate

    Measured: Up to approximately 24 months

  3. DOR

    Duration of Response

    Measured: Up to approximately 24 months

  4. OS

    Overall Survival

    Measured: Up to approximately 24 months

  5. TEAE

    Treatment Emergent Adverse Events

    Measured: Up to approximately 24 months

  6. Cmax

    Maximum serum concentration

    Measured: Up to approximately 24 months

  7. Tmax

    Time to maximum serum concentration

    Measured: Up to approximately 24 months

  8. Ctrough

    Minimum serum concentration

    Measured: Up to approximately 24 months

  9. ADA

    anti-SI-B001 antibody

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted26 Aug 2021
  2. Study start13 Dec 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022654
Sponsor's protocol ID
SI-B001_207
Status last verified
Sep 2025
First submitted
22 Aug 2021
Last updated
26 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SI-B001 and Irinotecan in people with Esophageal Squamous Cell Carcinomas, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites 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 12 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

ORR (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. 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 NCT05022654.

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 26 Sep 2025.

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