Clinical trial · Interventional
A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer
A Multi-Center, Randomized Controlled, Phase II Clinical Study Of Camrelizumab With Or Without Radiotherapy For The Treatment Of Recurrent Or Metastatic Esophageal Cancer That Has Progressed After Chemotherapy
NCT04512417CI-TRIAL-00046605unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Camrelizumab+Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combined radiotherapy group
- interventionNames
- Drug: Camrelizumab+Radiotherapy
- type
- EXPERIMENTAL
- label
- Immunotherapy alone group
- interventionNames
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) per RECIST 1.1
- timeFrame
- Up to 24 months
- description
- PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures; * 2\. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions; * 3\. Progress after first-line chemotherapy; * 4\. There are lesions measurable according to RECIST standards * 5\. Age ≥18 years old and ≤75 years old, regardless of gender * 6\. ECOG physical strength status score is 0~2; * 7\. Have not received immunotherapy or biological therapy before; * 8\. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L; * 9\. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min; * 10\. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL; * 11\. No history of interstitial pneumonia or previous interstitial pneumonia; Exclusion Criteria: * 1\. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug; * 2\. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed; * 3\. Metastasis of meninges, pleura or pericardium; * 4\. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity; * 5\. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia: * 6\. Patients who cannot understand the test requirements or may not comply with the test requirements; * 7\. Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin that does not require systemic treatment Diseases (such as vitiligo, psoriasis); * 8\. Active hepatitis B or C that requires treatment; * 9\. Suffered from an active infection requiring systemic treatment 14 days before the first administration; * 10\. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years; * 11\. The researcher believes that some obvious diseases should be excluded from this research; * 12\. The dose limit of radiotherapy cannot meet the limit requirement set by this study.
References
Publications (0)
Data not yet available
No reference posted for this study.