Combining camrelizumab with chemoradiotherapy for 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
This study is testing if adding a new immunotherapy drug called camrelizumab to standard chemotherapy and radiation can help people with advanced esophageal cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | camrelizumab, chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 1 site (Fuzhou) |
| Trial ID | NCT05624099 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of camrelizumab, an immunotherapy drug, when combined with chemoradiotherapy and chemotherapy in patients with advanced esophageal cancer who have not received prior systemic treatment. It is a prospective single-arm exploratory study focusing on patients with esophageal squamous cell carcinoma at advanced stages. Participants will receive a regimen that includes camrelizumab, Paclitaxel, platinum drugs, and radiation therapy to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced esophageal squamous cell carcinoma who have not previously undergone systemic anti-tumor therapy.
Not a fit: Patients with prior systemic anti-tumor therapy for esophageal cancer or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced esophageal cancer.
How similar studies have performed: While there have been studies exploring immunotherapy in esophageal cancer, the specific combination of camrelizumab with chemoradiotherapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Neutrophil count ≥ 1.0×10\^9/L
Platelet count ≥ 80×109/L
Hemoglobin ≥ 80 g/L
2. 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
9. Subjects have good compliance and cooperate with follow-up
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;
7. 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;
8. 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;
9. 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;
10. 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;
11. 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;
12. 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);
13. 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.
Where this trial is running
Fuzhou
- Fujian Cancer Hospital — Fuzhou, China (Recruiting)
Study contacts
- Study coordinator: Jiancheng Li, Doctor
- Email: jianchengli6@126.com
- Phone: 13906900190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.