Last reviewed · How we verify
NCT07034118
Definitive Proton Radiotherapy Combined With Chemotherapy and Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase I Clinical Study
Phase 1 trial testing Proton radiotherapy in Esophageal Carcinoma in 23 participants. Not yet recruiting.
31 August 2027
Quick facts
| Lead sponsor | Anhui Provincial Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 1 August 2025 |
| Primary completion | 31 August 2027 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Proton radiotherapy
- Immune Checkpoint Inhibitors — full drug profile →
Conditions studied
- Esophageal Carcinoma — all drugs for Esophageal Carcinoma →
Sponsor
Anhui Provincial Hospital
Who can join
Adults 18 to 75, any sex, with Esophageal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC) is definitive concurrent chemoradiotherapy (CCRT). However, conventional photon-based radiotherapy is associated with excessive radiation exposure to normal tissues and a high incidence of treatment-related toxicities. Proton radiotherapy, one of the major advances in radiation oncology in recent years, offers the dosimetric advantage of reduced radiation to surrounding normal tissues, thereby decreasing the rate of adverse events. Two recent clinical studies have suggested that, compared with conventional photon radiotherapy, proton radiotherapy can significantly reduce the incidence of treatment-related toxicities and potentially improve patient survival outcomes. Immune checkpoint inhibitors (ICIs) have been widely used in both locally advanced and advanced esophageal cancer and have demonstrated promising clinical efficacy. Preliminary results from several ongoing phase III clinical trials indicate that combining ICIs with concurrent chemoradiotherapy is both safe and effective. Moreover, proton radiotherapy, by minimizing the low-dose radiation exposure to circulating peripheral lymphocytes, may better preserve systemic immune function. Therefore, compared to photon therapy, proton radiotherapy may theoretically enhance the synergistic effect when combined with ICIs, offering a potential survival benefit. Based on this rationale, we propose a phase I clinical trial to investigate the safety and preliminary efficacy of definitive proton chemoradiotherapy combined with immune checkpoint inhibition in patients with locally advanced esophageal squamous cell carcinoma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07034118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Proton radiotherapy
Trials testing the same drug.
- NCT06999694 — Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC · Phase 2 · recruiting
- NCT06677879 — A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer. · Phase 2 · recruiting
- NCT06311968 — The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor · Phase 2 · recruiting
- NCT06133062 — Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT04462042 — Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma · NA · recruiting
Other recruiting trials for Esophageal Carcinoma
Currently open trials in the same condition.
- NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
- NCT07108855 — Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green Duri · Phase 1, PHASE2 · recruiting
- NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
- NCT06872515 — Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal) · NA · recruiting
- NCT06995898 — The Vanguard Study: Testing a New Way to Screen for Cancer · NA · recruiting
Other Anhui Provincial Hospital trials
Trials by the same sponsor.
- NCT07523464 — Centrally Confined 8Gy/1f to Tumor Core Followed by Concurrent Chemoradiotherapy for Unresectable Stage III NSCLC · Phase 1 · not yet recruiting
- NCT07481656 — Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT) · Phase 4 · not yet recruiting
- NCT07462676 — Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT. · NA · not yet recruiting
- NCT07211048 — Anti CD19 Gene Therapy for B-cell Lymphoma · NA · recruiting
- NCT07279844 — An Open-label, Observational, Long-term Follow-up Study Evaluating the Safety and Efficacy of RGL-193 Putamen Injection · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07034118 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Anhui Provincial Hospital
- Last refreshed: 24 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07034118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing