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Esophageal NeoplasmsPhase 2NCT05624099

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

A Phase 2 study testing camrelizumab, Paclitaxel drugs and Platinum drug in people with Esophageal Neoplasms and Esophageal Diseases, run by Fujian Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
camrelizumab, Paclitaxel drugs and Platinum drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
1 Aug 2023to 31 Dec 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign written informed consent and voluntarily participate in this study;
  • Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;
  • Survival is expected to exceed 3 months
  • Age 18-75;
  • ECOG PS 0-2
  • Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
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  • Have at least one measurable lesion
  • Normal function of major organs, including:
  • Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)
  • White blood cell count ≥ 3.0×10^9/L
  • Neutrophil count ≥ 1.0×10^9/L
  • Platelet count ≥ 80×109/L
  • Hemoglobin ≥ 80 g/L
  • Blood biochemical examination:
  • Total bilirubin ≤ 1.5×ULN
  • ALT ≤2.5×ULN, AST ≤2.5×ULN,
  • Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min
  • Subjects have good compliance and cooperate with follow-up

Who cannot join

  • The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;
  • Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;
  • Gastrointestinal bleeding (bleeding volume > 200ml/ day);
  • Patients with deep ulcers as determined by the investigator;
  • Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;
  • Has received or is receiving any of the following medical treatment:
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  • any radiation, chemotherapy or other antitumor drugs for the tumor;
  • Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted;
  • Received live attenuated vaccine within 4 weeks before the first administration of the study drug;
  • Major surgery or severe trauma within 4 weeks before the first use of the study drug;
  • A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included;
  • A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to:
  • Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention;
  • Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;
  • Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
  • The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit);
  • In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Trial locations and contacts

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

Jiancheng Li, Doctor contact

13906900190

jianchengli6@126.com

China1 site, 1 recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

Other trials in China

About this study

Official title: Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

Being tested
camrelizumab, Paclitaxel drugs, Platinum drug, Radiation
Keywords
Immunotherapy, Platinum, radiotherapy, Paclitaxel
Medical subject headings
Esophageal Neoplasms, Esophageal Diseases, Digestive System Neoplasms

What participants receive

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

  • camrelizumabDrug

    200mg intravenous drip d1q3w

  • Paclitaxel drugsDrug

    150mg/m2 d1 q3w

  • Platinum drugDrug

    Cisplatin, carboplatin, nedaplatin and other platinum drugs

  • RadiationRadiation

    Dose: 5040cGy/28f

Study groups in NCT05624099
Study groupRoleWhat they receive
drugExperimental1. camrelizumab 200mg intravenous drip d1q3w 2. Paclitaxel: 150mg/m2 d1 q3w 3. Platinum: Cisplatin, carboplatin, nedaplatin and other platinum drugs 4. Radiotherapy dose: 5040cGy/28f radiotherapy efficacy evaluation after 2-3 cycles of chemotherapy PR/SD received local radiotherapy.
Receives: Drug: camrelizumab; Drug: Paclitaxel drugs; Drug: Platinum drug; Radiation: Radiation

What is being measured

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

  1. Objective Response Rate(ORR)

    ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

    Measured: 3 years

Secondary outcomes (2)

  1. Overall survival(OS)

    Defined as the time from the enrollment to death from any cause

    Measured: 3 years

  2. Progression free survival(PFS)

    It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: 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 posted21 Nov 2022
  2. Study start1 Aug 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624099
Sponsor's protocol ID
Advanced immunotherapy CRT
Status last verified
Oct 2023
First submitted
13 Nov 2022
Last updated
19 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing camrelizumab, Paclitaxel drugs and Platinum drug in people with Esophageal Neoplasms and Esophageal Diseases, run by Fujian Cancer 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 18 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: looking for participants now, as of the sponsor's last update on 19 Oct 2023. 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?

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 Jiancheng Li, Doctor (13906900190, jianchengli6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: 3 years). 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 NCT05624099.

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 19 Oct 2023.

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