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An open and exploratory clinical study of camrelizumab combined with radiotherapy and chemotherapy in the treatment of locally advanced/advanced esophageal cancer

An open and exploratory clinical study of camrelizumab combined with radiotherapy and chemotherapy in the treatment of locally advanced/advanced esophageal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041171
Enrollment
Unknown
Registered
2020-12-20
Start date
2021-01-14
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal squamous cell carcinoma

Interventions

Group 1:Concurrent radiotherapy and chemotherapy
Group 2:Carrelizumab + concurrent radiotherapy and chemotherapy
group 3:Carrelizumab + chemotherapy, sequential radiotherapy + carrelizumab

Sponsors

Affiliated Cancer Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Esophageal squamous cell carcinoma confirmed by histology (stage IIA-IVA of the neck and upper thoracic segment; IIB-IVA of the middle and lower segment contains supraclavicular lymph node metastasis); 2. Have measurable tumor lesions (spiral CT scan >= 10mm, meet RECIST 1.1 standard); 3. Expected survival time> 3 months; 4. Aged >= 18 years old, no gender limit; 5. ECOG PS: 0-2 points; 6. The functions of important organs meet the following requirements: a) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 9g/dL; b) Bilirubin 60 mL/min; 7. Women of childbearing age must take a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use it uninterruptedly during the treatment period and 6 months after the last therapeutic dose. Contraceptive measures 8. The patient voluntarily joined the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Suffer from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. The patient has a history of radiotherapy; 3. The patient has perforated esophagus; 4. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 5. People with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected; 7. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 8. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 9. A history of psychotropic drug abuse, alcohol or drug abuse; 10. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 11. The researcher thinks it is inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Disease control rate;Progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactJianyu Xu

Affiliated Cancer Hospital of Harbin Medical University

13804605732@163.com+86 13804605732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026