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AzTrials

Esophagus CancerPhase 2NCT05637268

Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Camrelizumab, Paclitaxel and Cisplatin in people with Esophagus Cancer, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophagus Cancer
What is being tested?
Camrelizumab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
26 Nov 2020to 1 Jun 2025
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

  • Histologically confirmed thoracic esophageal squamous cell carcinoma (after R0 resection);
  • Lymph node metastases without distant metastases (pM0);
  • ECOG PS score: 0 ~ 1
  • The enrolled patients were expected to tolerate the combination therapy and survive for more than 6 months.
  • The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days): - Neutrophils 1.5×10⁹/L - platelet count 100×10⁹ /L - hemoglobin 5.6 mmol/L (9g/dL); 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); - Upper limit of normal 1.5 times total bilirubin (TBIL) (ULN); - 2.5 times the upper limit of normal (ULN) for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels; Urine protein <2 +; If the urine protein is ≥2+, the 24-hour urine egg white quantification shows that the protein must be ≤1g
  • Coagulation function is normal, no active bleeding and thrombotic disease
  • Non-surgical sterilization or female patients of childbearing age who are required to use a medically approved contraceptive method (such as an IUD, birth control pill or condom) during the study treatment period and for 3 months after the study treatment period ends; Female patients of childbearing age who were not surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; And it must be non-lactation; Male patients with non-surgical sterilization or of childbearing age need to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends
  • The subjects voluntarily participated in the study with good compliance and safety and survival follow-up

Who cannot join

  • Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy and immunotherapy or other targeted therapy;
  • Imaging evidence of distant metastasis;
  • Patients with esophageal squamous cell carcinoma after R1 or R2 resection;
  • The subject has had or co-had other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ);
  • Patients who had received carrilizumab or other PD-1/PD-L1 treatment in the past could not be enrolled; The subject is known to have a prior allergy to macromolecular protein preparations, or is known to be allergic to any carrilizumab, purple or platinum components;
  • Subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with purpura or complete remission of childhood asthma without any intervention as adults could be included; Patients with asthma requiring medical intervention with bronchodilators were not included);
Show all 18Show fewer
  • Subjects who were taking immunosuppressant or systemic or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use it within 2 weeks prior to enrollment;
  • Ascites or pleural effusion with clinical symptoms, requiring therapeutic puncture or drainage;
  • Patients with poorly controlled cardiac clinical symptoms or diseases, such as :(1) heart failure of NYHA2 or above, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
  • Abnormal coagulation function (PT>16s APTT>43s TT>21s Fbg>2g/L), bleeding inclination or receiving thrombolytic or anticoagulant therapy;
  • Subjects with active infection or unexplained fever >38.5 degrees prior to initial administration during screening (subjects with tumor-related fever, as determined by the investigator, could be enrolled);
  • Abdominal fistula and gastrointestinal perforation or abdominal abscess occurred less than 4 weeks before medication;
  • Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of lung function;
  • Subjects with congenital or acquired immune dysfunction, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA 10 /ml; Hepatitis C reference: HCV RNA 10 3 /ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml(< 104 copies /ml) must also receive antiviral therapy during the trial to be enrolled;
  • Subjects are participating in other clinical studies or less than 1 month after the end of the previous clinical study; Subjects may receive other systemic antitumor therapies during the study;
  • Live vaccine was administered less than 4 weeks before or possibly during the study period;
  • The subject has a known history of psychotropic substance abuse, alcohol abuse or drug use;
  • The researcher considers that the subjects should be excluded from the study. For example, the researcher judges that the subjects have other factors that may cause the study to be terminated, such as other serious diseases (including mental illness). Concomitant treatment is required, there are serious laboratory abnormalities associated with family or social factors that may affect the safety of the subject or the collection of data and samples.

Trial locations and contacts

1 site in 1 country.

Peng M Tang, archiater contact

18526812877

18526812877@163.com

China1 site, 1 recruiting

  • Affiliated Cancer Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

    Peng Tang, 18526812877, 18526812877@163.com

    Recruiting

Other trials in China

About this study

Official title: Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Node-positive Thoracic Esophageal Squamous Cell Carcinoma: a One-arm, Phase II Clinical Study

This is a single-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma.

Read the detailed description

Treatment with carrilizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal.

vial card Rayleigh bead sheet resistance: intravenous drip, fixed dose of 200 mg, with 30 minutes to an intravenous drip

(The overall infusion time including the flushing time shall be no less than 20 minutes, no longer than 60 minutes), Day 1, every repeat once every 2 weeks.

paclitaxel: 150 mg/m2, intravenous drip for 30 minutes, 1 day, every 14 days for a cycle.

cisplatin: 50 mg/m2, 2 days, every 14 days for a cycle.

A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.

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 Suzhou Shengdia Biological Medicine Co., LTD

    Camrelizumab 200mg iv q2w

  • PaclitaxelDrug

    150mg/m² iv d1 q2w

  • CisplatinDrug

    50 mg/m² iv d2 q2w

Study groups in NCT05637268
Study groupRoleWhat they receive
treatment groupExperimentalTreatment with camrelizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal. A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.
Receives: Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin

What is being measured

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

  1. 3-year DFS rate

    The probability of 3-year disease-free survival

    Measured: 8 weeks

Secondary outcomes (3)

  1. DFS

    disease-free survival

    Measured: From date of randomization until the date of first documented progression, assessed up to 60 months

  2. 3 years OS rate

    The probability of 3-year overall survival

    Measured: 8 weeks

  3. 5 years OS rate

    The probability of 5-year overall survival

    Measured: 8 weeks

Timeline

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

  1. First posted5 Dec 2022
  2. Study start26 Nov 2020
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 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
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637268
Sponsor's protocol ID
Peng Tang
Status last verified
Nov 2022
First submitted
14 Nov 2022
Last updated
5 Dec 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, Paclitaxel and Cisplatin in people with Esophagus Cancer, 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 8 inclusion and 18 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 5 Dec 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 M Tang, archiater (18526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year DFS rate (time frame: 8 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 NCT05637268.

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 5 Dec 2022.

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