Skip to content

A clinical study of the intensive neoadjuvant strategy in the treatment of locally advanced esophageal squamous cell carcinoma

A clinical study of the intensive neoadjuvant strategy of toripalimab combined with concurrent chemoradiotherapy and sequential chemotherapy in the treatment of locally advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085206
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-10
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 Squamous Carcinoma

Interventions

A :toripalimab combined with concurrent chemoradiotherapy and sequential chemotherapy

Sponsors

Affiliated hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-75, male or female 2.Have a performance status of 0 or 1 on the ECOG Performance Scale 3.Locally advanced esophageal cancer diagnosed by pathology, Clinical tumor stage should be T T2-4aN0-1M0 according to the 8th edition of the AJCC staging system 4.The expression level of PD-L1 was detected. 5.Have at least one measurable lesion according to RECIST version 1.1 evaluation criteria, CT scan =10mm; 6.Immunohistochemical tests were performed to determine the expression intensity of EGFR, including weak positive (+), moderate positive (++) and strong positive (+++) 7.Blood biochemical indexes in the normal range; 8.Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) 9.Ability to understand the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.); 2.Participating in other interventional clinical trials within 30 days prior to screening 3.Patients with distant metastasis; 4.Patients with primary malignant tumors other than esophageal cancer (except cured cervical carcinoma in situ, breast carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); 5.There are autoimmune diseases; People with interstitial lungs or who are receiving immunosuppressive therapy; poorly controlled comorbidities (e.g., heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 6.Presence of HIV infection or active viral hepatitis; 7.Allergic to the drugs or their components used in this program; 8.= grade 2 peripheral nerve disease or hearing loss according to NCI CTCAE V5.0; 9.Women who are pregnant (confirmed by blood or urine HCG testing) or breastfeeding, or subjects of childbearing age who are unwilling or unable to use effective contraception (for both male and female) until at least 6 months after the last trial treatment; 10.The researchers think that it is not appropriate to participate in the research; 11.Those who do not want to participate in the study or are unable to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Pathologic complete response rate (pCR);

Secondary

MeasureTime frame
Treatment feasibility;Safety;

Countries

China

Contacts

Public ContactZhou Jialiang

Affiliated Hospital of Jiangnan University

aaronyoyo@sina.com+86 137 7108 5468

Outcome results

None listed

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