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Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

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

NCT05624099•Fujian Cancer Hospital

View on ClinicalTrials.gov

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 cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign written informed consent and voluntarily participate in this study;
•2. 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;
•3. Survival is expected to exceed 3 months
•4. Age 18-75;
•5. ECOG PS 0-2
•6. Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
•7. Have at least one measurable lesion
•8. Normal function of major organs, including:
•1. 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
+8 more criteria

Exclusion Criteria

•1. The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;
•2. 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;
•3. Gastrointestinal bleeding (bleeding volume \> 200ml/ day);
•4. Patients with deep ulcers as determined by the investigator;
•5. Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;
•6. Has received or is receiving any of the following medical treatment:
•1. any radiation, chemotherapy or other antitumor drugs for the tumor;
•2. 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;
•3. Received live attenuated vaccine within 4 weeks before the first administration of the study drug;
•4. Major surgery or severe trauma within 4 weeks before the first use of the study drug;
+8 more criteria

Locations (1)

Fujian Cancer Hospital

Fuzhou, China

Key Dates

Start Date

August 1, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 31, 2027

Last Updated

October 19, 2023

Enrollment

ESTIMATED participants

Conditions

Esophageal NeoplasmsEsophageal DiseasesDigestive System Neoplasms

Interventions

camrelizumab

DRUG

Paclitaxel drugs

DRUG

Platinum drug

DRUG

Radiation

RADIATION

Contacts

Jiancheng Li, Doctor

CONTACT

13906900190 jianchengli6@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

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