Esophageal Squamous Cell CarcinomaPhase 2/3ESCC-PTNCT07653451
Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer
A Phase 2/3 study testing Afatinib + Toripalimab, Dalpiciclib + Pyrotinib and Camrelizumab + Apatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University Cancer Hospital & Institute.
Trial summary
This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Afatinib + Toripalimab, Dalpiciclib + Pyrotinib and Camrelizumab + Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent from previous studies and age ≥18 years.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
- Locally advanced, unresectable, or metastatic ESCC that progressed on or after standard second-line or later therapy containing immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 antibodies, or bispecific antibodies).
- At least one measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Anticipated life expectancy ≥12 weeks.
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- Adequate organ and bone marrow function within 14 days prior to the first dose (without blood transfusion, EPO, G-CSF, or other hematologic supports), as defined by:
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelet count ≥100×109/L
- Hemoglobin ≥9 g/dL (or ≥5.6 mmol/L)
- Serum albumin >30 g/L
- Serum creatinine ≤1.5×ULN (Upper Limit of Normal) or calculated creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula)
- Total bilirubin ≤1.5×ULN
- AST and ALT ≤2.5×ULN (≤5.0×ULN for patients with documented liver metastases, provided total bilirubin is within normal limits)
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN, and activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN
- Female patients of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to the first dose. WOCBP and male patients with WOCBP partners must agree to use highly effective contraception from signing the informed consent throughout the treatment period and for at least 6 months after the last dose. (Highly effective methods include oral/implanted hormonal contraceptives, intrauterine devices [IUDs], or barrier methods combined with spermicide. Postmenopausal women aged >50 years must have been amenorrheic for ≥12 months to be considered postmenopausal).
- Required washout periods prior to the first dose of study treatment are as follows:
- Systemic anticancer therapies (chemotherapy, targeted therapy, immunotherapy, biological therapy, or hormonal therapy) or participation in clinical trials: >4 weeks.
- Systemic small-molecule targeted therapies: >2 weeks or 5 half-lives (whichever is longer).
- Prior Chinese herbal medicine with anti-tumor activity: >2 weeks.
- Prior major surgery or radiotherapy: >4 weeks (palliative radiotherapy for bone metastases: >2 weeks).
Who cannot join
- Currently receiving concurrent antitumor therapies (including chemotherapy, systemic therapy, immunotherapy, radiotherapy, or surgery) at the time of enrollment.
- History of other malignancies within the past 3 years (except for cured thyroid cancer, cervical carcinoma in situ, basal/squamous cell skin cancer, or other cured localized tumors with disease-free survival >3 years).
- Adverse events (AEs) from prior antitumor therapies that have not resolved to baseline or Grade ≤1 (excluding alopecia, Grade 2 anemia, or irreversible, clinically insignificant, asymptomatic laboratory abnormalities).
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose, or not fully recovered from surgical procedures; or plans for surgery during the study period.
- Active peripheral neuropathy (PN) or neurotoxicity ≥ Grade 2, history of Grade 3 neurotoxicity/PN, or prior permanent discontinuation of treatment due to neurotoxicity/PN.
- Active pneumonitis/interstitial lung disease (ILD), history of pulmonary radiation within 12 months prior to the first dose, or clinically significant underlying pulmonary disease (e.g., chronic obstructive pulmonary disease).
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- Symptomatic or active central nervous system (CNS) metastases requiring intervention (including steroid therapy with prednisone >10 mg/day or equivalents, or anticonvulsants) within 4 weeks prior to the first dose.
- Any other severe underlying medical condition, including but not limited to: uncontrolled diabetes, active infections, vaccination within 4 weeks, active peptic ulcer, uncontrolled epilepsy, cerebrovascular accident within 6 months, gastrointestinal bleeding within 3 months, or clinical signs of coagulopathy.
- Clinically significant cardiovascular disease, including:
- Left ventricular ejection fraction (LVEF) ≤50% or below the institutional lower limit of normal (LLN) determined by echocardiography (ECHO) or MUGA scan (if ECHO is unavailable).
- Heart failure classified as NYHA Class ≥III.
- Uncontrolled hypertension (systolic BP ≥150 mmHg and/or diastolic BP ≥95 mmHg despite optimal medical therapy).
- Prior or current cardiomyopathy.
- Unstable angina, or myocardial infarction within 6 months.
- Serious arrhythmia requiring medical intervention (excluding controlled atrial fibrillation or paroxysmal supraventricular tachycardia).
- QTc interval ≥450 ms for males, or ≥470 ms for females (using Fridericia's formula), or history of congenital long QT syndrome.
- Dyspnea due to advanced malignancy complications or other diseases, requiring continuous supplemental oxygen therapy at rest.
- Any other severe psychiatric, psychological, familial, or geographical conditions that, in the investigator's opinion, could interfere with study compliance, protocol execution, follow-up, or place the patient at high risk of treatment-related complications.
- History of HIV infection or positive HIV serology.
- Active viral hepatitis B or C (Note: Patients with HBV are eligible if HBV DNA is within the normal range/suppressed on antivirals; patients with positive HCV antibody are eligible if HCV RNA is undetectable via PCR). Frequent viral load monitoring is mandatory.
- History of life-threatening allergies, known hypersensitivity to any study drug components, recombinant proteins, or excipients, or intolerance to EGFR antibodies or eribulin.
- Pregnant or lactating women.
- Any concurrent medical condition that, in the investigator's clinical judgment, could compromise protocol compliance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors
This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle [Q4W]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Afatinib + Toripalimab, Dalpiciclib + Pyrotinib, Camrelizumab + Apatinib
- 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.
Afatinib + ToripalimabDrug
Patients in this cohort will receive Afatinib at a dose of 40 mg orally (p.o.) once daily (Q.D.) combined with Toripalimab at a dose of 240 mg intravenously (i.v.) every 3 weeks (Q21D). Treatment will continue in 21-day cycles until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Toripalimab administration is capped at a maximum duration of 24 months.
Dalpiciclib + PyrotinibDrug
Patients will receive Dalpiciclib at a dose of 125 mg p.o. Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle (Q4W), in combination with Pyrotinib maleate at a dose of 320 mg p.o. Q.D. administered within 30 minutes post-meal (Q4W). Treatment will continue until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, or withdrawal of consent.
Camrelizumab + ApatinibDrug
Patients in this cohort will receive a triple-combination therapy consisting of Camrelizumab (200 mg i.v. every 3 weeks [Q3W]), and Apatinib (250 mg p.o. Q.D.). Efficacy evaluations will be performed every 6 weeks. Treatment will continue until radiographic disease progression, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| EGFR High Expression or Pathway Activation | Experimental | This treatment arm comprises patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy and exhibit high EGFR expression or activation of EGFR-related signaling pathways determined by ctDNA sequencing. Receives: Drug: Afatinib + Toripalimab |
| Cell Cycle Pathway Alteration | Experimental | This treatment arm comprises patients with advanced ESCC refractory to prior immunotherapy harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways based on ctDNA profiling. Receives: Drug: Dalpiciclib + Pyrotinib |
| Other Molecular Subtypes | Experimental | This treatment arm comprises patients with advanced ESCC refractory to prior immunotherapy whose tumors present other molecular profiles not meeting the criteria for Cohorts 1 or 2. Receives: Drug: Camrelizumab + Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) defined as the time from the first dose to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: 1 year
Secondary outcomes (2)
Overall Survival (OS)
Overall Survival (OS) defined as the time from the first dose to death from any cause.
Measured: 1 year
Objective Response Rate (ORR)
Objective Response Rate (ORR) as assessed by RECIST v1.1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653451
- Sponsor's protocol ID
- ESCC-PT
- Acronym
- ESCC-PT
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07653451
- Acronym / sponsor ID
- ESCC-PT / ESCC-PT
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle [Q4W]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EGFR High Expression or Pathway Activation | Experimental | Drug: Afatinib + ToripalimabThis treatment arm comprises patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy and exhibit high EGFR expression or activation of EGFR-related signaling pathways determined by ctDNA sequencing. |
| Cell Cycle Pathway Alteration | Experimental | Drug: Dalpiciclib + PyrotinibThis treatment arm comprises patients with advanced ESCC refractory to prior immunotherapy harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways based on ctDNA profiling. |
| Other Molecular Subtypes | Experimental | Drug: Camrelizumab + ApatinibThis treatment arm comprises patients with advanced ESCC refractory to prior immunotherapy whose tumors present other molecular profiles not meeting the criteria for Cohorts 1 or 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed written informed consent from previous studies and age ≥18 years.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
- Locally advanced, unresectable, or metastatic ESCC that progressed on or after standard second-line or later therapy containing immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 antibodies, or bispecific antibodies).
- At least one measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (23 listed)
- Currently receiving concurrent antitumor therapies (including chemotherapy, systemic therapy, immunotherapy, radiotherapy, or surgery) at the time of enrollment.
- History of other malignancies within the past 3 years (except for cured thyroid cancer, cervical carcinoma in situ, basal/squamous cell skin cancer, or other cured localized tumors with disease-free survival >3 years).
- Adverse events (AEs) from prior antitumor therapies that have not resolved to baseline or Grade ≤1 (excluding alopecia, Grade 2 anemia, or irreversible, clinically insignificant, asymptomatic laboratory abnormalities).
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose, or not fully recovered from surgical procedures; or plans for surgery during the study period.
- Active peripheral neuropathy (PN) or neurotoxicity ≥ Grade 2, history of Grade 3 neurotoxicity/PN, or prior permanent discontinuation of treatment due to neurotoxicity/PN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib + ToripalimabPatients in this cohort will receive Afatinib at a dose of 40 mg orally (p.o.) once daily (Q.D.) combined with Toripalimab at a dose of 240 mg intravenously (i.v.) every 3 weeks (Q21D). Treatment will continue in 21-day cycles until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Toripalimab administration is capped at a maximum duration of 24 months. | Drug | EGFR High Expression or Pathway Activation |
| Dalpiciclib + PyrotinibPatients will receive Dalpiciclib at a dose of 125 mg p.o. Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle (Q4W), in combination with Pyrotinib maleate at a dose of 320 mg p.o. Q.D. administered within 30 minutes post-meal (Q4W). Treatment will continue until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, or withdrawal of consent. | Drug | Cell Cycle Pathway Alteration |
| Camrelizumab + ApatinibPatients in this cohort will receive a triple-combination therapy consisting of Camrelizumab (200 mg i.v. every 3 weeks [Q3W]), and Apatinib (250 mg p.o. Q.D.). Efficacy evaluations will be performed every 6 weeks. Treatment will continue until radiographic disease progression, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. | Drug | Other Molecular Subtypes |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 1 year
Progression-Free Survival (PFS) defined as the time from the first dose to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
2 secondary outcomes
Overall Survival (OS)
Time frame: 1 year
Objective Response Rate (ORR)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Afatinib + Toripalimab, Dalpiciclib + Pyrotinib and Camrelizumab + Apatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University Cancer Hospital & Institute.
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 21 inclusion and 23 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (010-88196561, pppeirain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.