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Evaluation of efficacy and prognosis of immunotherapy for esophageal cancer based on liquid biopsy techniques: a prospective observational study

Evaluation of efficacy and prognosis of immunotherapy for esophageal cancer based on liquid biopsy techniques: a prospective observational study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070588
Enrollment
Unknown
Registered
2023-04-17
Start date
2023-04-17
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

esophageal cancer

Interventions

Gold Standard:clinical outcome
Index test:5mC

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 at the time of signing the informed consent; 2. Patients with late locally advanced esophageal cancer confirmed by histopathological examination; 3. Have not received immune checkpoint therapy drugs (PD-1/PD-L1/CTLA4, etc.), and have not previously undergone surgery, chemotherapy, radiotherapy or targeted therapy; 4. At least one measurable tumor lesion was present according to RECISTv1.1 criteria; 5. No central nervous system metastasis occurred; 6. The ECOG PS score is 0 or 1; 7. Patients or family members are willing to cooperate with complete medication tracking requirements

Exclusion criteria

Exclusion criteria: 1. The patient has metastases of brain and other nervous system; 2. Acute or chronic hepatitis B or C infection; 3. Active, known or suspected autoimmune diseases (except type I diabetes, hypothyroidism requiring hormone replacement therapy, skin diseases, etc., without systemic treatment); 4. Prior malignancies (other than carcinoma in situ such as lung, bladder, stomach, colon, endometrial, breast, etc.), unless they had been in complete remission at least 2 years prior to study participation and no additional treatment was required during the study period; 5. Received any chemotherapy, biologics for cancer, or experimental therapies within 28 days prior to initial dosing; 6. Patients who refused or could not complete the communication related to informed consent of the study, or patients who withdrew from the study for some reason during the study; 7. Consult the researcher for other exclusions.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactWang Xin

Cancer Hospital, Chinese Academy of Medical Sciences

xiaowuxian2006@126.com+86 13811176181

Outcome results

None listed

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