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Thoracic Esophageal Squamous Cell CarcinomaPhase 2NCT04937673

The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Camrelizumab+Albumin bound paclitaxel+Cisplatin and Camrelizumab+ Paclitaxel+ Cisplatin in people with Thoracic Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab+Albumin bound paclitaxel+Cisplatin and Camrelizumab+ Paclitaxel+ Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jul 2021to 1 Dec 2022
Phase
Phase 2
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

  • Age: 18-75 years old, male or female;
  • Esophageal squamous cell carcinoma was confirmed by pathology (except for cervical and Suprathoracic tumors that could not be operated);
  • Patients with resectable esophageal squamous cell carcinoma with clinical stage T3-T4a or TxN + M0 (except T4b);
  • ECOG PS score was 0-1;
  • There was at least one measurable lesion (according to recist1.1) or unmeasurable lesion that could be evaluated, and the imaging diagnosis time was ≤ 21 days;
  • The expected survival time was more than 3 months;
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  • The function of the main organs was normal, and there were no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency diseases. The laboratory examination meets the following requirements:
  • Hemoglobin (Hb) ≥ 90g / L;
  • WBC ≥ 3.0 × 109/L； Neutrophil count (NEUT) ≥ 1.5 × 109/L；
  • Platelet count (PLT) ≥ 100 × 109/L；
  • Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml / min (Cockcroft Gault formula);
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  • The levels of AST and ALT were less than 2.5 times the upper limit of normal (ULN);
  • There was no active bleeding or thrombosis
  • International normalized ratio INR ≤ 1.5 × ULN；
  • Partial thromboplastin time APTT ≤ 1.5 × ULN；
  • Prothrombin time Pt ≤ 1.5ULN;
  • The patients with normal or mild to moderate abnormal lung function (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco> 40%) could tolerate esophagectomy;
  • The fertile female subjects were required to conduct blood pregnancy test within 72 hours before the first administration, and the result was negative, and voluntarily used appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug; For men, surgical sterilization or consent to appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug should be used.
  • The subjects voluntarily joined the study and signed the informed consent form (ICF);
  • The patients with good compliance were expected to follow up the efficacy and adverse events / reactions according to the protocol requirements.

Who cannot join

  • Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy;
  • Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
  • Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
  • Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
  • Live attenuated vaccine was inoculated within 4 weeks before the first administration or during the study period;
  • Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
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  • Subjects with uncontrollable clinical cardiac symptoms or diseases, such as (1) heart failure of NYHA II or above (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
  • Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown origin > 38.5% occurred during the screening period / before the first administration；
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known;
  • Pregnant or lactating women; The fertile subjects were unwilling or unable to take effective contraceptive measures;
  • Other malignant tumors were found in the past or at the same time, but the cured basal cell carcinoma of skin, carcinoma in situ of cervix and carcinoma in situ of breast were excluded;
  • Known to have allergic history to the drug components of this protocol;
  • Other situations considered unsuitable by the researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of GI Oncology, Peking University Cancer Hospital,

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Camrelizumab Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma：A Phase II Clinical Study to Explore the Relationship Between Biomarkers and Efficacy

This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.

Being tested
Camrelizumab+Albumin bound paclitaxel+Cisplatin, Camrelizumab+ Paclitaxel+ Cisplatin

What participants receive

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

  • Camrelizumab+Albumin bound paclitaxel+CisplatinDrug

    Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.

    Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks.

    Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

  • Camrelizumab+ Paclitaxel+ CisplatinDrug

    Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.

    Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks.

    Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

Study groups in NCT04937673
Study groupRoleWhat they receive
Camrelizumab+ Paclitaxel+ CisplatinExperimentalThe subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation). At the end of the treatment, the patients were followed up for safety and effectiveness.
Receives: Drug: Camrelizumab+ Paclitaxel+ Cisplatin
Camrelizumab+ Albumin bound paclitaxel+ CisplatinExperimentalThe subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation). At the end of the treatment, the patients were followed up for safety and effectiveness.
Receives: Drug: Camrelizumab+Albumin bound paclitaxel+Cisplatin

What is being measured

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

  1. biomarkers related to pCR

    t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer.

    Measured: 9 weeks

Secondary outcomes (5)

  1. Objective Response Rate

    Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.

    Measured: 9 weeks

  2. Disease Control Rate

    Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.

    Measured: 9 weeks

  3. Disease free survival

    The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment.

    Measured: Time from randomization to patient's tumor progression or death

  4. Overall Survival

    OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier

    Measured: The time from the beginning of randomization to death due to any cause.

  5. Safety

    Adverse events

    Measured: from first treatment to 90 days after esophagectomy

Timeline

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

  1. First posted24 Jun 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Dec 2022 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04937673
Sponsor's protocol ID
MA-EC-II-005
Status last verified
Jun 2021
First submitted
28 May 2021
Last updated
24 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab+Albumin bound paclitaxel+Cisplatin and Camrelizumab+ Paclitaxel+ Cisplatin in people with Thoracic Esophageal Squamous Cell Carcinoma, run by Peking University 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 21 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Jun 2021. 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 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?

Results are not available in the source record.

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?

biomarkers related to pCR (time frame: 9 weeks). 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 NCT04937673.

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 24 Jun 2021.

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