OncoMatch

OncoMatch/Clinical Trials/NCT06684600

Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

Is NCT06684600 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dalpiciclib + Pyrotinib for esophageal squamous cell carcinoma.

Phase 2RecruitingPeking UniversityNCT06684600Data as of May 2026

Treatment: Dalpiciclib + PyrotinibThe purpose of this study is to observe and evaluate the efficacy and safety of dalpiciclib combined with pyrotinib as second-line therapy in patients with advanced esophageal squamous cell carcinoma.

Check if I qualify

Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: systemic chemotherapy — first-line

Patients undergoing first-line systemic chemotherapy progression or intolerance (progress in maintenance therapy after first-line chemotherapy can also be included). Synchronous chemoradiotherapy for postoperative recurrence or metastasis is considered as first-line treatment; For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure.

Cannot have received: radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular-targeted therapy

Exception: eligible if last dose of anti-neoplastic medication was discontinued for ≥5 half-lives before the initial treatment

Prior radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular-targeted therapy within 4 weeks of enrollment (eligible for enrollment if the last dose of anti-neoplastic medication was discontinued for ≥5 half-lives before the initial treatment); prior chemotherapy with nitrosoureas or mitomycin within 6 weeks of enrollment.

Cannot have received: chemotherapy with nitrosoureas or mitomycin

prior chemotherapy with nitrosoureas or mitomycin within 6 weeks of enrollment

Cannot have received: concurrent anti-neoplastic treatments

Concurrent administration of other anti-neoplastic treatments

Lab requirements

Blood counts

ANC≥1.5×10^9/L; PLT≥90×10^9/L; HB≥90g/L; ALB≥28g/L; APTT and INR ≤1.5 × ULN

Kidney function

plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min

Liver function

TBIL≤1.5 × ULN,ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN

The main organs function normally, that is, the following criteria are met: ANC≥1.5×10^9/L; PLT≥90×10^9/L; HB≥90g/L; ALB≥28g/L; TBIL≤1.5 × ULN,ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; APTT and INR ≤1.5 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify