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Real-World clinical study of cindimizumab combined with chemotherapy in neoadjuvant treatment of resectable esophageal cancer

Real-World clinical study of cindimizumab combined with chemotherapy in neoadjuvant treatment of resectable esophageal cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050561
Enrollment
Unknown
Registered
2021-08-28
Start date
2021-10-08
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Esophagus cancer

Interventions

Case series:None

Sponsors

Zhangzhou Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. The patient's age is >=18 years old; 3. Patients diagnosed with esophageal cancer through histopathological examination of primary tumor biopsy; 4. Patients who are judged to be operable by imaging and esophagoscopy and need neoadjuvant therapy (cT2-3, N1-2M0), stage II-III; 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. The patient has not received any anti-tumor therapy before, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 7. ECOG score 0-1 points.

Exclusion criteria

Exclusion criteria: 1. Receive a live attenuated vaccine within 4 weeks before enrollment or plan to receive a live attenuated vaccine during the study; 2. Active, known or suspected autoimmune disease; 3. Known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Pregnant or breastfeeding female patients. 6. Untreated acute or chronic active hepatitis B or C infection. For patients receiving antiviral therapy, under the condition of monitoring the number of virus copies, the doctor will judge whether they are eligible for inclusion according to the individual situation of the patient; 7. Uncontrolled concurrent diseases, including but not limited to: (1) HIV-infected persons (HIV antibody positive); (2) Serious infection in active stage or poorly controlled clinically; (3) The presence of severe or uncontrolled systemic disease (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [i.e. Refers to evidence of greater than or equal to CTCAE grade 2 hypertension after drug treatment]). 8. Those with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or have bleeding tendency.

Design outcomes

Primary

MeasureTime frame
Complete pathological remission;

Secondary

MeasureTime frame
Major pathological remission;Safety;Disease free survival time;

Countries

China

Contacts

Public ContactZhang Yi

Zhangzhou Affiliated Hospital of Fujian Medical University

1164757136@qq.com+86 13960191636

Outcome results

None listed

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