AzTrials
AzTrials

Locally Advanced Unresectable Esophageal Squamous CarcinomaPhase 1/2NCT06136988

A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

A Phase 1/2 study testing Docetaxel for Injection (Albumin-bound), SG001 and Cisplatin for injection in people with Locally Advanced Unresectable Esophageal Squamous Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel for Injection (Albumin-bound), SG001 and Cisplatin for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
2 sitesChina
Study dates
Dec 2023to Apr 2028
Phase
Phase 1/2
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

  • Age ≥ 18 years (based on the day of signing the informed consent form).
  • Voluntarily sign the informed consent, willing and able to follow the protocol for visits, treatment and laboratory tests.
  • Locally advanced (stage II-IVa and IVb supraclavicular lymph node metastases according to AJCC 8th edition) esophageal squamous carcinoma (in the case of mixed adenosquamous carcinoma, more than 50% squamous carcinoma component can be screened) diagnosed histologically or cytologically, which is unresectable in the judgment of the principal investigator, and is amenable to definitive chemoradiotherapy (dCRT) .
  • ECOG score of 0-1 within 7 days prior to the first dose.
  • Vital organ function within 7 days prior to first dose, meeting the following criteria (no blood transfusions, no use of human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), and erythropoietin (EPO) within 14 days prior to the first dose):
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
Show all 14Show fewer
  • Platelet count (PLT) ≥ 100×10^9/L
  • Hemoglobin ≥ 80g/L
  • Serum albumin ≥ 28g/L
  • Total bilirubin ≤1.0×ULN; ALT/AST ≤1.5×ULN
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min, Cockcroft-Gault formula
  • Activated Prothrombin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 x ULN.
  • Female patients of childbearing age tested negative serum pregnancy test within 7 days prior to the first dose, and patients must agree to take effective contraception from the signing of the informed consent form until 6 months after the last dose, during which time breastfeeding is not allowed; male patients must agree to take contraception and sperm donation is not allowed.
  • Have at least one evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

Who cannot join

  • Active malignancy within 5 years prior to the first dose, except esophageal carcinoma studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or early-stage thyroid cancer, etc).
  • History of esophageal perforation and/or esophageal fistula within 6 months prior to the first dose; or significant tumor invasion into an organ adjacent to the esophageal lesion (aorta or trachea), etc., resulting in a high risk of hemorrhage, esophageal fistula, or signs of esophageal perforation.
  • Uncontrollable plasma effusions requiring frequent drainage or medical intervention (e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) within 7 days prior to the first dose that require additional interventions within 2 weeks of the intervention (excluding exfoliative cytology of the exudate).
  • Weight loss of 20% or more within 3 months prior to the first dose; or BMI <18.5 kg/m^2 and/or weight <30 kg.
  • Severe allergy history to albumin or docetaxel, paclitaxel, cisplatin, or monoclonal antibody drugs.
  • Patients who have received prior antitumor therapy for esophageal cancer.
Show all 26Show fewer
  • Patients with immunodeficiency or active autoimmune disease (except a. well-controlled type I diabetes b. hypothyroidism [controlled with hormone replacement therapy] c. well-controlled celiac disease d. dermatologic that do not require systemic therapy [e.g., vitiligo, psoriasis, alopecia] e. any other condition not expected to recur in the absence of external triggers).
  • History of severe cardiovascular disease within 6 months prior to the first dose, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, Third-degree atrioventricular block
  • History of myocardial infarction, unstable angina, angioplasty, coronary artery bridging surgery
  • Heart failure with New York Heart Association (NYHA) classification of class III and above
  • Left ventricular ejection fraction (LVEF) <50% at screening period
  • Patients with prolonged QT/QTc interval on ECG at baseline (QTcF > 480ms, Fridericia formula: QTcF=QT/RR^0.33, RR=60/heart rate).
  • Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during the screening period).
  • Patients with active Hepatitis B (Hepatitis B surface antigen (HBsAg) or HBcAb positive test and active stage of Hepatitis B (HBV-DNA ≥ 10^4 cps/mL or ≥ 2000 IU/mL)); Hepatitis C (Hepatitis C Antibody (Anti-HCV) positive test and a positive PCR result for HCV RNA); positive for HIV, during the screening period.
  • Patients with poorly controlled diabetes mellitus, or hypokalemia, hyponatremia, or abnormal values on corrected calcium lab tests (CTCAE 5.0 >1 grade) despite of standard drug therapy within 14 days prior to the first dose.
  • History of interstitial lung disease or non-infectious pneumonia.
  • Patients with known psychoneurologic disorders that may affect adherence to the trial, and those with a history of drug dependence;
  • Patients with severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose. Note: Antiviral therapy for patients with viral hepatitis is permitted.
  • Have received potent inhibitors or potent inducers of CYP2C8 (for Phase Ⅱ trials only) or CYP3A4 within 14 days prior to the first dose.
  • Vaccination with a live or live attenuated vaccine (inactivated vaccines are permitted) within 28 days prior to the first dose.
  • History of major organ surgery (excluding puncture biopsy) within 28 days prior to the first dose.
  • Patients who have received antitumor therapy such as other clinical investigational drugs within 28 days prior to the first dose.
  • Patients who have received systemic glucocorticoid therapy (dose > 10 mg/day of prednisone or equivalent) within 28 days prior to the first dose.
  • Any condition that, in the opinion of the investigator, makes participation in the study inappropriate (including, but not limited to, concurrent serious or uncontrolled medical conditions, potential safety risks, interference with the interpretation of the results of the study, and adherence to the trial).
  • The patient is concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or is in the follow-up period of an interventional study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

+86-0311-69085587

ctr-contact@cspc.cn

China2 sites

  • Shandong Tumor Hospital

    Jinan, Shandong

    Jin ming Yu, 86-531-67627156, sdyujinming@126.com

  • Tianjin cancer institute &hospital

    Tianjin, Tianjin Municipality

    Qing song Pang, 86-18622221203, pangqingsong2016@163.com

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase Ib/II Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy Versus Paclitaxel in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma.

Read the detailed description

This study will be conducted in two stages. The first stage (Phase Ib) is a dose-escalation study designed to determine the safety and the recommended Phase 2 dose (RP2D) of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma. Patients will be assigned to receive sequentially higher doses of HB1801 once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 60 mg/m^2. The second stage (Phase II) is a study to evaluate the efficacy and safety of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

Being tested
Docetaxel for Injection (Albumin-bound), SG001, Cisplatin for injection, Paclitaxel, Simultaneous Radiotherapy

What participants receive

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

  • Docetaxel for Injection (Albumin-bound)Drug

    Also called HB1801

    Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m^2, Intravenous infusion, Q3W

  • SG001Drug

    Also called Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection

    Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W

  • Cisplatin for injectionDrug

    Cisplatin for injection, 25 mg/m^2, Intravenous infusion, D1-D3, Q3W

  • PaclitaxelDrug

    Paclitaxel 135 mg/m^2, Intravenous infusion, Q3W

  • Simultaneous RadiotherapyRadiation

    Radiotherapy (28×1.8Gy)

Study groups in NCT06136988
Study groupRoleWhat they receive
HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapyExperimentalSG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; Docetaxel for Injection (Albumin-bound) (HB1801), Intravenous infusion, D1, Q3W, 60 or 75 mg/m^2, up to 2 cycles; cisplatin for injection 25 mg/m^2, D1-D3, Q3W, up to 2 cycles; radiotherapy (28×1.8Gy).All treatments will be administered until disease progression or intolerable toxicity.
Receives: Drug: Docetaxel for Injection (Albumin-bound); Drug: SG001; Drug: Cisplatin for injection; Radiation: Simultaneous Radiotherapy
Paclitaxel in combination with cisplatin and simultaneous radiotherapyActive comparatorPaclitaxel 135 mg/m^2, Intravenous infusion, D1, Q3W; cisplatin for injection 25 mg/m^2, D1-D3, Q3W, radiotherapy (28×1.8Gy). No other systemic antineoplastic therapy is allowed until disease progression, optimal supportive care and local palliative care are allowed.
Receives: Drug: Cisplatin for injection; Drug: Paclitaxel; Radiation: Simultaneous Radiotherapy

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. Determine the recommended Phase 2 dose (RP2D) of Docetaxel for Injection (Albumin-bound)

    Measured: At the end of Cycle 2 (each cycle is 21 days)

  3. Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ib

    Measured: up to 4 years

  4. PFS as determined by the investigator according to RECIST 1.1 in Phase Ⅱ

    Measured: up to 4 years

Secondary outcomes (7)

  1. Objective remission rate (ORR)

    Measured: up to 4 years

  2. Disease control rate (DCR)

    Measured: up to 4 years

  3. Duration of remission (DOR)

    Measured: up to 4 years

  4. Progression-free survival (PFS)

    Measured: up to 4 years

  5. Overall survival (OS)

    Measured: up to 4 years

  6. Incidence of SG001 antidrug antibodies and neutralizing antibodies (if applicable)

    Measured: up to 4 years

  7. Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ⅱ

    Measured: up to 4 years

Timeline

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

  1. First posted18 Nov 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136988
Sponsor's protocol ID
HB1801-008
Status last verified
Nov 2023
First submitted
8 Nov 2023
Last updated
18 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docetaxel for Injection (Albumin-bound), SG001 and Cisplatin for injection in people with Locally Advanced Unresectable Esophageal Squamous Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 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 14 inclusion and 26 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: opening soon, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined 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.

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?

Contact Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 4 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 NCT06136988.

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 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in