WithdrawnPhase 2

Neoadjuvant Immunotherapy to ESCC

Stopped: insufficient money

China0Started 2020-12

Plain-language summary

Currently, surgery after neoadjuvant chemoradiotherapy is the standard treatment for patients with locally advanced esophageal cancer, but the recurrence rate is high and the 5-year survival rate is low. Immunotherapy shows a potential treatment for esophageal cancer. Immunocheckpoint (PD-1/PD-L1) inhibitors can activate tumor immunity. The guidelines have recommended it as a sencond-line therapy. However, there is still lack of the evidence for its efficacy as a neoadjuvant therapy. This study is to conduct a randomized controlled, open label, phase II clinical trial to evaluate the efficacy and safety of neoadjuvant immnotherapy combined with neoadjuvant chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC) patient with PD-L1 (CPS\>=10%) positive.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Volunteer to participated and sign information consent;
✓. Age 18-70, male or female;
✓. Locally advanced esophageal cancer diagnosed by pathology, Clinical tumor stage should be II-IVa; tumor located at the lower middle segment;
✓. No previous chemoradiotherapy or immunotherapy;
✓. PD-L1 expression \>=10%;
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale;
✓. Demonstrate adequate organ function as defined below (excluding the use of any blood components and cytokines during the screening period): Absolute neutrophil count (ANC) ≥1.5\*109 /L; Platelet ≥100\*109/L; Hemoglobin ≥ 9 g/dL; Serum albumin≥3g/dL; Bilirubin≤1.5 x ULN; ALT and AST≤2.5 ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40mL/min; LVEF\>=50%; Urine protein\<++; INR\<1.5 and APTT\<1.5;
✓. Female subject must have taken reliable contraceptive measures of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. Male subject should agree to use appropriate contraceptive methods or to have been surgically sterilized during the trial and 8 weeks after the last administration of the test drug.

What they're measuring

Major Pathological Response (MPR) rate

Timeframe: 30 days after the second cycle of treatment(each cycle is 21 days)

Trial details

NCT IDNCT04625543

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06

View on ClinicalTrials.gov More Esophagus SCC trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Volunteer to participated and sign information consent;
✓. Age 18-70, male or female;
✓. Locally advanced esophageal cancer diagnosed by pathology, Clinical tumor stage should be II-IVa; tumor located at the lower middle segment;
✓. No previous chemoradiotherapy or immunotherapy;
✓. PD-L1 expression \>=10%;
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale;
✓. Demonstrate adequate organ function as defined below (excluding the use of any blood components and cytokines during the screening period): Absolute neutrophil count (ANC) ≥1.5\*109 /L; Platelet ≥100\*109/L; Hemoglobin ≥ 9 g/dL; Serum albumin≥3g/dL; Bilirubin≤1.5 x ULN; ALT and AST≤2.5 ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40mL/min; LVEF\>=50%; Urine protein\<++; INR\<1.5 and APTT\<1.5;
✓. Female subject must have taken reliable contraceptive measures of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. Male subject should agree to use appropriate contraceptive methods or to have been surgically sterilized during the trial and 8 weeks after the last administration of the test drug.

Neoadjuvant Immunotherapy to ESCC

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Neoadjuvant Immunotherapy to ESCC

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria