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Study on the efficacy of Camrelizumab plus chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma

Study on the efficacy of Camrelizumab plus chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039638
Enrollment
Unknown
Registered
2020-11-04
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

Esophageal squamous cell carcinoma

Interventions

treatment group:Camrelizumab plus chemotherapy
control group:chemotherapy

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with esophageal squamous cell carcinoma diagnosed by cytology or histology; 2. Those patients who agree to collect tumor tissue and peripheral blood samples needed for research and apply them to relevant research; 3. Patients with advanced esophageal cancer who can be surgically resected without any treatment and without surgical contraindications; 4. Patients who agree to accept radical surgery; 5. Patients with at least one measurable lesion (RECIST v1.1); 6. 18 years old <= patient age <= 75 years old, male or female; 7. Patients with ECoG score 0; 8. Patients who have signed the written informed consent and can follow the visit and related procedures specified in the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine treatment (except for the treatment of malignant tumor with no recurrence and metastasis for more than 5 years); 2. Patients who had used immunosuppressive drugs within 3 weeks before the first dose of study treatment (excluding prednisone not exceeding 10 mg / day or other glucocorticoids of equivalent dose); 3. Patients with known or suspected active autoimmune diseases; 4. Patients with known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 5. Patients allergic to any component of monoclonal antibody; 6. Patients with other uncontrolled serious diseases; 7. Patients with other acute or chronic diseases that may interfere with the test results of the study; 8. Physical examination or clinical examination findings that researchers believe may increase the risk of adverse reactions.

Design outcomes

Primary

MeasureTime frame
overall response rate(ORR);Major Pathologic Response(MPR);pathologic complete response(pCR);

Secondary

MeasureTime frame
R0 resection rate;disease free survival(DFS);recurrence rate(RR);survival rate(SR);

Countries

China

Contacts

Public ContactZhiming Chen

Huashan Hospital Affiliated to Fudan University

Chzm_md@163.com+86 13916015668

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026