Combining immunotherapy and chemoradiotherapy for esophageal cancer treatment
Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial
This study is testing if combining a new immunotherapy drug with traditional chemoradiotherapy can help people with advanced esophageal cancer have better treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy, cardonilizumab |
| Locations | 3 sites (Anyang, Henan and 2 other locations) |
| Trial ID | NCT06421376 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of cardonilizumab, an immunotherapy agent, in combination with chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma (ESCC). The trial aims to improve treatment outcomes for patients who have a poor prognosis with current therapies. Eligible participants will undergo a regimen that includes both immunotherapy and chemoradiotherapy, followed by potential radical surgery. The study will assess the response to treatment and monitor any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed locally advanced esophageal squamous cell carcinoma.
Not a fit: Patients with other primary malignant tumors or those with severely compromised organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced esophageal cancer.
How similar studies have performed: Other studies have shown promising results with multimodal treatments for esophageal cancer, but the specific combination of cardonilizumab with chemoradiotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-80 years old； * Eligible patients were histologically confirmed esophageal squamous cell carcinoma; * Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system； * ECOG PS score: 0\~1； * Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL; Exclusion Criteria: * Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * patients who had previously received other treatments * At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites * Those who already have esophageal perforation or are at high risk of esophageal perforation * Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the * there are active infections, such as active tuberculosis and hepatitis * There are contraindications to immunotherapy. * Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures * Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes. * Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.
Where this trial is running
Anyang, Henan and 2 other locations
- Anyang Cancer Hospital — Anyang, Henan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Not_yet_recruiting)
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Xin Wang — Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
- Study coordinator: Xin Wang, M.D.
- Email: beryl_wx2000@163.com
- Phone: +8601087787635
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.