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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 (Jun 2026). This Phase 2 trial studies Dalpiciclib + Pyrotinib for esophageal squamous cell carcinoma.

Phase 2RecruitingPeking UniversityNCT06684600Data as of Jun 2026Location: China

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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Dalpiciclib + Pyrotinib

Cancer type

Esophageal Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06684600 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular-targeted therapy, chemotherapy with nitrosoureas or mitomycin, concurrent anti-neoplastic treatments disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

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

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