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Advanced Esophageal Squamous Cell CarcinomaPhase 2ANSWERNCT05214222

Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Anlotinib/Penpulimab/Chemotherapy and Penpulimab/Chemotherapy in people with Advanced Esophageal Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical 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

Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib/Penpulimab/Chemotherapy and Penpulimab/Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
2 Sep 2022to 2 Sep 2028
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

  • Patients with stage III-IV esophageal squamous cell carcinoma who are not candidates for curative treatment (excluding adenosquamous carcinoma mixed type);
  • Those who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;
  • According to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);
  • Patients between 18 and 75 years old;
  • ECOGPS score: 0~1 points; the expected survival period is more than 3 months;
  • Tumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.
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  • It has sufficient organ and bone marrow function, that is, it meets the following standards:
  • The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥100×10^9/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
  • Post-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;
  • For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;
  • Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.
  • For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.

Who cannot join

  • It is known that esophageal squamous cell carcinoma tends to be completely obstructed under endoscopy and requires interventional treatment to relieve the obstruction;
  • Patients with ulcerative esophageal squamous cell carcinoma;
  • Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;
  • Patients with esophageal squamous cell carcinoma whose esophageal lesions have not been reduced after radiotherapy without surgical resection of the primary lesion;
  • Allergy to paclitaxel and cisplatin preparations or excipient ingredients;
  • Patients who have used paclitaxel or cisplatin in adjuvant chemotherapy and have relapsed or metastasized within six months; Note: Those who have relapsed or metastasized for more than six months can be included in the study;
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  • Previously received anti-tumor immunotherapy (including immune checkpoint inhibitors, immune cell therapy, etc.) or anti-angiogenesis targeted therapy drugs (including antibodies and small molecule tyrosine kinase inhibitors);
  • There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), but patients who have difficulty swallowing and can drink, can take Anlotinib after dissolving the granules;
  • The burden of liver metastases accounts for more than 50% of the entire liver volume;
  • Patients with any severe and/uncontrolled diseases, including:
  • Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); patients with grade II or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥480ms); according to NYHA standards , Grade III-IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%;
  • Active or uncontrolled serious infection;
  • Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;
  • Poor control of diabetes (fasting blood glucose (FBG)> 10mmol/L);
  • Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0g;
  • Long-term unhealed wounds or fractures;
  • Patients with esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion; pulmonary hemorrhage with NCICTCAE grade> grade 1 occurred within 4 weeks before enrollment; other sites with NCICTCAE grade> grade 2 occurred within 4 weeks before enrollment Bleeding; patients with bleeding tendency (such as active peptic ulcer) or who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues;
  • Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose of the study or expected major surgery during the study treatment period.
  • A history of gastrointestinal perforation and/or fistula in the 6 months before the enrollment treatment; or arteriovenous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and lungs Embolizer
  • There are known symptomatic central nervous system metastases and/or cancerous meningitis;
  • Ascites with clinical significance, including any ascites that can be found on physical examination, ascites that has been treated in the past or still needs to be treated at present, only those with a small amount of ascites but asymptomatic on imaging can be selected;
  • Patients with moderate pleural effusion on both sides, or large pleural effusion on one side, or patients who have caused respiratory dysfunction and require drainage;
  • Known to have active tuberculosis;
  • Suffer from interstitial lung disease that requires steroid therapy;
  • Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or cancer secondary reactions, which may lead to higher medical risks and/or uncertainty in survival evaluation;
  • Patients with significant malnutrition, BMI<13.6kg/m2;
  • People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
  • Have a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  • History of other primary malignant tumors, except for the following: 1) Malignant tumors that have been completely remitted for at least 2 years before enrollment and no other treatment is required during the study period; 2) Non-melanoma skin that has been adequately treated and has no evidence of disease recurrence Carcinoma or malignant freckle-like nevus; 3) Carcinoma in situ that has been adequately treated and has no evidence of disease recurrence;
  • Female patients who are pregnant or breastfeeding;
  • According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.

Trial locations and contacts

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

wei wang contact

020-61642136

wwei9500@smu.edu.cn

China1 site, 1 recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    wei wang

    Recruiting

Other trials in China

About this study

Official title: Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study

Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study.

Read the detailed description

This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then penpulimab will be used every 3 weeks until disease progression, Anlotinib and Penpulimab will be used every 3 weeks until disease progression again or intolerance;

Being tested
Anlotinib/Penpulimab/Chemotherapy, Penpulimab/Chemotherapy
Keywords
PD-1 inhibitor/anlotinib

What participants receive

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

  • Anlotinib/Penpulimab/ChemotherapyDrug

    Also called Anlotinib, Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin

    Initial treatment (4-6 cycles): Anlotinib, Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin

    • Anlotinib: once a day, 1 capsule each time (10mg for body weight <60KG, 12mg for body weight ≥60KG), d1-d14, 3 weeks as a treatment cycle.
    • Penpulimab: 200 mg, d1 per cycle, once every 3 weeks.
    • Paclitaxel: According to 135-175mg/m2, intravenous infusion> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle.
    • Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle.

    Maintenance treatment: Anlotinib, Penpulimab

    • Anlotinib: once a day, 1 capsule each time (the same as the initial treatment dose), take the drug every cycle d1-d14, 3 weeks as a treatment cycle.
    • Penpulimab: 200mg, d1 per cycle, once every 3 weeks

  • Penpulimab/ChemotherapyDrug

    Also called Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin

    Initial treatment (4-6 cycles): Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin

    • Penpulimab: 200 mg, d1 per cycle, once every 3 weeks.
    • Paclitaxel: According to 135-175mg/m2, intravenous infusion> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle.
    • Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle.

    Maintenance treatment: Penpulimab

    • Penpulimab: 200mg, d1 per cycle, once every 3 weeks Post-progression genetic testing, continued treatment: Anlotinib,Penpulimab Anlotinib: Once daily, one capsule per time (10mg for weight <60KG, 12mg for weight ≥60KG), administered from day 1 to day 14 of each cycle. Two consecutive weeks of treatment followed by one week off, 3 weeks per treatment cycle.

    Penpulimab: 200mg, administered on day 1 of each cycle, every 3 weeks.

Study groups in NCT05214222
Study groupRoleWhat they receive
group AExperimentalPenpulimab plus chemotherapy with Anlotinib
Receives: Drug: Anlotinib/Penpulimab/Chemotherapy
group BExperimentalPenpulimab plus chemotherapy
Receives: Drug: Penpulimab/Chemotherapy

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1

    Measured: up to approximately 2 year

Secondary outcomes (9)

  1. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or a Stable Response per RECIST 1.1

    Measured: up to approximately 2 year

  2. Progression Free Survival (PFS) include PFS1,PFS2

    PFS was defined as the time from first day of study treatment to the first documented PD or death due to any cause during the specific treatment period, whichever occurred first

    Measured: up to approximately 2 year

  3. Overall Survival (OS)

    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up

    Measured: up to approximately 3 year

  4. Safety: AE

    Safety was defined as the Number of Participants With an Adverse Event

    Measured: up to approximately 2 year

  5. Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

    The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall quality of life (QoL) during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL EORTC QLQ-C30 score in participants will be presented.

    Measured: up to approximately 2 year

  6. Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)

    The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants will be presented.

    Measured: up to approximately 2 year

  7. The 1-year OS rate

    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up

    Measured: 1 year

  8. The 2-year OS rate

    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up

    Measured: 2 years

  9. The 3-year OS rate

    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up

    Measured: 3 years

Timeline

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

  1. First posted28 Jan 2022
  2. Study start2 Sep 2022
  3. Primary completion2 Jun 2026 (estimated)
  4. Study completion2 Sep 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05214222
Sponsor's protocol ID
NFEC-2021-405
Acronym
ANSWER
Status last verified
Dec 2024
First submitted
3 Jan 2022
Last updated
30 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib/Penpulimab/Chemotherapy and Penpulimab/Chemotherapy in people with Advanced Esophageal Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical 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 12 inclusion and 31 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 30 Dec 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 wei wang (020-61642136, wwei9500@smu.edu.cn), 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: up to approximately 2 year). 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 NCT05214222.

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 30 Dec 2024.

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