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Individualized radiotherapy plus PARP inhibitors in locally advanced esophageal cancer

Individualized radiotherapy plus PARP inhibitors in locally advanced esophageal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086484
Enrollment
Unknown
Registered
2024-07-02
Start date
2024-07-02
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Interventions

Treatment Group:Radiotherapy: 50.4 Gy in 28 fractions, from Monday to Friday in weeks 1 to 5, and from Monday to Wednesday in week 6, for a total of 6 weeks. Pamiparib 40mg orally twice a day, from Mo

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Pathological histology confirms primary esophageal squamous cell carcinoma. ? Received radiotherapy and is intolerant or refuses concurrent chemoradiotherapy. ? Has measurable lesions (non-lymph node metastatic lesions with a long axis >10 mm, lymph node lesions with a short axis >15 mm). Refer to RECIST criteria version 1.1. ? Life expectancy is =3 months. ? Age of the subject is over 18 years old. ? Can swallow medication normally. ? If there is a risk of conception, male and female subjects must use effective contraception during the treatment process. ? Excludes contraindications for radiotherapy. ? The subject has given informed consent and has signed the relevant documents.

Exclusion criteria

Exclusion criteria: ? Concurrent treatment with PARP inhibitors not included in this trial protocol. ? Patients who are pregnant (confirmed by urine test) or breastfeeding. ? Patients with obvious symptoms of esophageal perforation. ? Patients who cannot understand the trial requirements or are likely not to comply with them. ? Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ, or malignant disease cured for =5 years. ? Other serious diseases affecting survival, such as extensive surgery or radiotherapy; uncontrollable active infections, severe bleeding, other complications; patients with uncontrolled diabetes, hypertension, and severe cardiovascular or pulmonary diseases. ? Other diseases that the researcher considers should be excluded from this study.

Design outcomes

Primary

MeasureTime frame
1-year progression-free survival time rate;

Secondary

MeasureTime frame
progression-free survival;Disease Control Rate,DCR;Disease Control Rate, DCR;

Countries

China

Contacts

Public ContactJingping Yu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

yujingping@njmu.edu.cn+86 137 7518 6392

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026