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

NCT06684600 | Recruiting Phase 2

• 1 other identifier: 2024YJZ118
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of subjects in the analysis population who achieved complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.

  an expected average of 24 months

Secondary Outcomes (4)

• Overall Survival（OS）

  an expected average of 24 months

• Progression-free Survival (PFS)

  an expected average of 24 months

• Disease Control Rate (DCR)

  an expected average of 24 months

• Adverse events

  an expected average of 24 months

Other Outcomes (1)

• Correlations between biomarkers and clinical activity

  an expected average of 24 months

Study Arms (1)

Dalpiciclib + Pyrotinib

EXPERIMENTAL

Drug: Dalpiciclib + Pyrotinib

Interventions

Dalpiciclib + Pyrotinib DRUG

Dalpiciclib Isethionate tablets, 125mg, oral administration on days 1 to 21, followed by a 7-day drug holiday, every 4 weeks; Pyrotinib Maleate tablets, 320mg, oral administration once daily on days 1 to 28, every 4 weeks; Treatment will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or the investigator determines that the subject should discontinue study treatment.

Dalpiciclib + Pyrotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~75 years, both men and women.；
• Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC), and local recurrence or distant metastasis；
• 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.
• At least one measurable/evaluable lesion by RECIST v1.1. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1 standard, can also be used as a target lesion).
• Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Capable of swallowing tablets normally.
• Life expectancy of ≥ 12 weeks.
• The main organs function normally, that is, the following criteria are met:
• ANC≥1.5×109/L
• PLT≥90×109/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.

You may not qualify if:

• Presence of clinically significant symptoms and uncontrollable third-space fluid accumulations, such as large pleural effusions or ascites, that cannot be managed through drainage or other methods.
• Chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction, among other factors that may affect medication intake and absorption.
• Prolonged corticosteroid therapy exceeding 30 days or requiring long-term corticosteroid use.
• 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.
• Unresolved adverse events related to prior treatments to less than grade 2 (excluding alopecia, asthenia, and adverse events deemed by the investigator not to affect eligibility).
• Participation in another clinical trial of a new drug within 4 weeks, unless the trial is observational (non-interventional) or in a follow-up phase.
• Persistent uncorrectable hypokalemia and hypomagnesemia at the time of enrollment.
• Symptomatic or untreated brain metastases.
• History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
• Concurrent administration of other anti-neoplastic treatments.
• Individuals with an allergic constitution or known hypersensitivity to any component of the study medication.
• Patients with a propensity for gastrointestinal bleeding, including but not limited to:
• \) Active ulcers with fecal occult blood (++); 2) History of melena or hematemesis within the past 2 months; 3) For fecal occult blood (+) and the primary tumor site not surgically removed, a gastroscopy is required, and patients with visible active bleeding are ineligible.
• \. Active infections, including but not limited to tuberculosis. 14. History of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• \. Severe cardiac conditions within the past 6 months, including but not limited to:

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Department of GI Oncology, Peking University Cancer Hospital,

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

dalpiciclib; pyrotinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Zhihao Lu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihao Lu, MD

CONTACT

13810549767; 13810549767@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)