AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT06684600

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

A Phase 2 study testing Dalpiciclib + Pyrotinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Dalpiciclib + Pyrotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Nov 2024to 30 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18~75 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.
Show all 18Show fewer
  • 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.
  • APTT and INR ≤1.5 × ULN
  • Female subjects of childbearing potential must undergo a blood pregnancy test within 72 hours prior to the first administration of the drug and the result must be negative. They must not be breastfeeding and must agree to use effective contraception during the trial period and for at least 7 months after the last use of Dalpiciclib or at least 8 weeks after the last use of Pyrotinib, whichever is longer. Male subjects with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the trial period and for at least 7 months after the last use of Dalpiciclib or at least 8 weeks after the last use of Pyrotinib, whichever is longer. Sperm donation is not allowed during the study period.
  • Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-u.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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:
  • 1) 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.
  • 13. 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.
  • 15. Severe cardiac conditions within the past 6 months, including but not limited to:
  • Acute coronary syndrome;
  • Clinically significant arrhythmias requiring medication or unable to discontinue medications that may prolong the QT interval during the study;
  • Acute myocardial infarction;
  • Heart failure;
  • Any other cardiac condition deemed unsuitable for trial participation by the investigator.
  • 16. Pregnant or lactating women, or women of childbearing potential with a positive baseline pregnancy test.
  • 17. Serious comorbidities judged by the investigator to endanger patient safety or impede study completion, such as hypertension, severe diabetes, thyroid disorders, etc.
  • 18. Habitual alcohol consumption, smoking (≥5 cigarettes daily), and other detrimental lifestyle habits; heavy episodic drinking is defined as consuming approximately four or more drinks within 2 hours, where one drink is equivalent to 150 mL of wine, 350 mL of beer, or 50 mL of 80-proof spirits.
  • 19. History of definite neurological or psychiatric disorders, including epilepsy or dementia.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhihao Lu, MD contact

13810549767

13810549767@126.com

China1 site, 1 recruiting

  • Department of GI Oncology, Peking University Cancer Hospital,

    Beijing, Beijing Municipality, 100142

    Zhihao Lu, MD

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Phase II Clinical Trial of Dalpiciclib Combined with Pyrotinib As Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

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.

Read the detailed description

The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a single-arm, phase II clinical trial of dalpiciclib combined with pyrotinib as second-line therapy in patients with advanced esophageal squamous cell carcinoma.

Being tested
Dalpiciclib + Pyrotinib
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dalpiciclib + PyrotinibDrug

    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.

Study groups in NCT06684600
Study groupRoleWhat they receive
Dalpiciclib + PyrotinibExperimentalNot described
Receives: Drug: Dalpiciclib + Pyrotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: an expected average of 24 months

Secondary outcomes (4)

  1. Overall Survival（OS）

    Time from initial treatment to the subject's death. At the end of the study, if the subject is still alive, the last known date of survival of the subject will be the date of deletion.

    Measured: an expected average of 24 months

  2. Progression-free Survival (PFS)

    Time from initial treatment to first radiographic disease progression (RECIST 1.1 criteria) or death, whichever occurs first.

    Measured: an expected average of 24 months

  3. Disease Control Rate (DCR)

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

    Measured: an expected average of 24 months

  4. Adverse events

    The incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined according to NCI-CTCAE v5.0 criteria.

    Measured: an expected average of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684600
Sponsor's protocol ID
2024YJZ118
Status last verified
Oct 2024
First submitted
10 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalpiciclib + Pyrotinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhihao Lu, MD (13810549767, 13810549767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: an expected average of 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in