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Esophageal CarcinomaPhase 2NCT05476380

Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing camrelizumab in people with Esophageal Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of neoadjuvant therapy of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Carcinoma
What is being tested?
camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
19 Feb 2021to 1 Dec 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Sign the written informed consent before joining the group;
  • 2) Age 18-70 years old, both male and female
  • 3) T3N+M0 patients with resectable esophageal squamous cell carcinoma confirmed by pathology and imaging（AJCC/UICC eighth edition TNM staging of esophageal cancer）
  • 4) Evaluation of patients with locally advanced surgical resection before treatment
  • 5) There are measurable lesions that meet the RECIST v1.1 criteria for evaluation;
  • 6) ECOG PS score: 0 to 1;
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  • 7) The expected survival period is greater than 6 months;
  • 8) It is allowed to take blood samples and postoperative pathological sections;
  • 9) The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
  • Blood routine:
  • Neutrophil ≥1.5*109/L
  • Platelet count≥100*109/L
  • Hemoglobin ≥ 90g/L;
  • Liver and kidney function:
  • Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification must show protein ≤ 1 g;
  • 10) Normal coagulation function, no active bleeding and thrombotic disease
  • International Standardized Ratio INR≤1.5×ULN;
  • Partial thromboplastin time APTT≤1.5×ULN;
  • Prothrombin time PT≤1.5ULN;
  • 11) Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period;Non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days prior to study enrollment; and must be non-lactating;Non-surgical sterilization or male patients of childbearing age need to agree to use a medically approved contraceptive method with their spouse during the study treatment period and within 3 months after the end of the study treatment period.
  • 12）The subjects voluntarily joined the study, with good compliance, and cooperated with safety and survival follow-up

Who cannot join

  • 1) Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy;
  • 2) Patients with distant metastasis confirmed by imaging;
  • 3) The subject has suffered from other malignant tumors in the past or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
  • 4) Previous treatment with camrelizumab or other PD-1/PD-L1 therapy; known subjects had previous treatment with macromolecular protein preparations, or known treatment with any camrelizumab, paclitaxel or platinum Allergic to ingredients;
  • 5) The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included );
  • 6) The subject is using immunosuppressive, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10mg/day prednisone or other equivalent hormones), and within 2 weeks before enrollment is still in use;
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  • 7) Ascites or pleural effusion with clinical symptoms requires therapeutic puncture or drainage;
  • 8) There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • 9) Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or receiving thrombolytic or anticoagulation therapy;
  • 10) The patient currently (within 3 months) has esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or the unresectable tumor has active bleeding, or the investigator determines other conditions that may cause gastrointestinal bleeding and perforation;
  • 11) Past or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient cerebral insufficiency) within 12 months blood attack);
  • 12) The subject has active infection or unexplained fever >38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subject's fever due to tumor can be enrolled);
  • 13) Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred less than 4 weeks before study medication;
  • 14) Patients with past and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.;
  • 15) Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 1000 IU/ml; hepatitis C reference: HCV RNA ≥ 103 IU/ml); Chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml, must receive antiviral therapy during the trial period before they can be enrolled;
  • 16) The subject is participating in other clinical studies or less than 1 month after the end of the previous clinical study; the subject may receive other systemic anti-tumor therapy during the study;
  • 17) Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period;
  • 18) The subject is known to have a history of psychotropic substance abuse, alcohol or drug abuse;
  • 19）The researcher believes that it should be excluded from this study. For example, according to the researcher's judgment, the subjects have other factors that may cause the study to be terminated midway. For example, other serious diseases (including mental diseases) require concomitant treatment. Abnormal laboratory tests, accompanied by family or social factors, will affect the safety of subjects, or the collection of data and samples.

Trial locations and contacts

1 site in 1 country.

Peng Tang, MD contact

18526812877

18526812877@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Peng Tang, MD, 18526812877, 18526812877@163.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Single-arm, Phase II Clinical Study

To evaluate the efficacy and safety of neoadjuvant therapy of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma

Read the detailed description

This study is a single-arm, open-label, exploratory clinical study, the main purpose of which is to evaluate the efficacy and safety of neoadjuvant treatment of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma.

The patient will receive three cycles of treatment of camrelizumab(200 mg, IV., d1, q3w), paclitaxel(175 mg/m2,continuous IV., d1, 24h q3w), cisplatin(75 mg/m2, iv., d1,q3w).Patients who are assessed as being able to undergo surgical resection receive elective resection surgery,and the maintenance treatment of postoperative patients implements individualized treatment.

Being tested
camrelizumab
Keywords
Esophageal Carcinoma, Camrelizumab, Neoadjuvant therapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • camrelizumabDrug

    Also called Paclitaxel, Cisplatin

    Camrelizumab:200 mg, IV., d1, q3w; Paclitaxel:175 mg/m2,continuous IV., d1, 24h q3w; Cisplatin:75 mg/m2, iv., d1,q3w

Study groups in NCT05476380
Study groupRoleWhat they receive
CCNT-ESCCExperimentalThis study is a single-arm, open-label, exploratory clinical study, the main purpose of which is to evaluate the efficacy and safety of neoadjuvant treatment of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received neoadjuvant treatment of carrelizumab combined with combined with chemotherapy.The patient will receive three cycles of treatment of camrelizumab(200 mg, IV., d1, q3w), paclitaxel(175 mg/m2,continuous IV., d1, 24h q3w), cisplatin(75 mg/m2, iv., d1,q3w).Patients who are assessed as being able to undergo surgical resection receive elective resection surgery,and the maintenance treatment of postoperative patients implements individualized treatment.
Receives: Drug: camrelizumab

What is being measured

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

  1. pCR

    pathological complete response rate

    Measured: within 28 working days after operation

Secondary outcomes (4)

  1. 1year DFS rate

    Disease-free survival in 1 year

    Measured: Refers to the time from initiation to tumor recurrence or death from any cause (up to approximately 1 year)

  2. Postoperative complication rate

    Postoperative complication rate

    Measured: within 28 working days after operation

  3. R0 resection rate

    the complete resection rate of all tumor under microscope

    Measured: within 28 working days after operation

  4. DFS

    Disease-free survival

    Measured: Refers to the time from initiation to tumor recurrence or death from any cause (up to approximately 3 years)

Timeline

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

  1. First posted27 Jul 2022
  2. Study start19 Feb 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2024 (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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476380
Sponsor's protocol ID
21-OBU-TJ-BB-EC-II-00
Status last verified
Dec 2021
First submitted
25 Jul 2022
Last updated
27 Jul 2022
Results posted
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 in people with Esophageal Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 23 inclusion and 19 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 27 Jul 2022. 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?

Contact Peng Tang, MD (18526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: within 28 working days after operation). 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 NCT05476380.

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 27 Jul 2022.

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