Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

NCT05624099 | Recruiting Phase 2

• 1 other identifier: Advanced immunotherapy CRT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Neoplasms; Esophageal Diseases; Digestive System Neoplasms

Keywords

Immunotherapy; Platinum; radiotherapy; Paclitaxel

Outcome Measures

Primary Outcomes (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.

  3 years

Secondary Outcomes (2)

• Overall survival(OS)

  3 years

• Progression free survival(PFS)

  3 years

Study Arms (1)

drug

EXPERIMENTAL

1. 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.

Drug: camrelizumab; Drug: Paclitaxel drugs; Drug: Platinum drug; Radiation: Radiation

Interventions

camrelizumab DRUG

200mg intravenous drip d1q3w

drug

Paclitaxel drugs DRUG

150mg/m2 d1 q3w

drug

Platinum drug DRUG

Cisplatin, carboplatin, nedaplatin and other platinum drugs

drug

Radiation RADIATION

Dose: 5040cGy/28f

drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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:
• 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 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;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Diseases; Digestive System Neoplasms

Interventions

camrelizumab; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Jiancheng Li, Doctor

CONTACT

13906900190; jianchengli6@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CN (1)