Esophageal CancerPhase 2EASOPCWAACNCT06586242
Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy
A Phase 2 study testing Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin in people with Esophageal Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2023to Apr 2036
- 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
- 1. only those who meet all the following requirements can be enrolled in this trial: 1. age 18-75 years old, both male and female;
- 2. according to gastroscope / ultrasonic gastroscope biopsy, the pathology suggests esophageal cancer, and the clinical diagnosis is ct2n1-3m0 or ct3n0-3m0 or ct4n0-3m0, and the TNM stage is stage ii-iva;
- 3. patients with non cervical esophageal cancer;
- 4. have not received previous systemic and local treatment for esophageal cancer according to RECIST 1 1 criteria at least one measurable lesion was used for imaging evaluation of neoadjuvant therapy;
- 5.ecog PS: 0-1 point;
- 6. estimated survival ≥ 12 months;
- 7. the subject had no dysfunction of major organs, and the investigator assessed that the thyroid, lung, bone marrow, liver, kidney and heart functions were basically normal; 8. women of childbearing age must have taken reliable contraceptive measures or had a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the test and - 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and 8 weeks after the last administration of the trial drug;
- 9. the subjects voluntarily joined the study, signed the informed consent, had good compliance, followed the planned schedule, actively cooperated with returning to the hospital for regular clinical follow-up and necessary treatment, and cooperated with regular blood and tissue sample acquisition.
Who cannot join
- 1. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- 2. patients with ulcerative esophageal squamous cell carcinoma;
- 3. patients with esophageal fistula or tracheal fistula;
- 4. those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
- 5. have a history of immune deficiency, including HIV positive or suffering from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- 6. patients with any severe and / or uncontrolled disease, including:
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- 1) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mmHg); 2) Myocardial ischemia or myocardial infarction of grade I or above; 3) Arrhythmia (including QT interval ≥ 480 MS) and grade I cardiac insufficiency; 4) Diabetes mellitus with poor blood glucose control (fasting blood glucose (FBG) >10mmol/l) or high-dose glucocorticoid treatment; 5) Active or uncontrolled severe infection; 6) Decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104copies/ml or 2000iu/ml) or hepatitis C (hepatitis C antibody and HCV RNA positive) were all above the lower limit of the analysis method; 7) Hyperthyroidism and hypothyroidism; 8) Active tuberculosis.
- 7. unrelieved toxic reactions higher than CTCAE grade 1 due to any previous treatment, excluding hair loss;
- 8. esophageal cancer patients with active bleeding within 2 months of the primary lesion;
- 9. patients whose tumors have invaded the important blood vessels or are judged by the investigator to be very likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage;
- 10. patients with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), but patients with dysphagia who can drink water, can take anlotinib after dissolving the particles;
- 11. the urine routine indicates that the urine protein is ≥ + +, and the 24-hour urine protein quantitation is confirmed to be >1.0 g;
- 12. received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before grouping;
- 13. abnormal coagulation function: inr>1.5 or prothrombin time (PT) >uln+4 seconds or APTT >1.5uln), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; Within 4 weeks before grouping, patients with any bleeding or bleeding events ≥ CTCAE grade 3 had unhealed wounds, ulcers or fractures;
- 14. Those who have had arterial / venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- 15. pregnant or lactating women;
- 16. patients with distant metastasis;
- 17. patients with significant myelosuppression;
- 18. have a history of mental illness or abuse of psychotropic drugs;
- 19. Patients who have participated in clinical trials of other drugs within 4 weeks;
- 20. according to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;
- 21. the investigator believes that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaan'xi, 710000
Liu Hong, master, 18792807591 ext. 0086, 18792804403@163.com
About this study
Official title: A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer
This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.
Read the detailed description
The study was a two arm, randomized, prospective, multicenter study. The experimental group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin, and the control group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin
- Conditions
- Esophageal Cancer
- Being tested
- Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatinDrug
Also called AK105；AL3818
200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, Penpulimab:administered on the first day of each cycle Anlotinib:Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w
| Study group | Role | What they receive |
|---|---|---|
| penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin | Experimental | penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week oxaliplatin：130mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle. Receives: Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin |
| penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin | Active comparator | penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week lobaplatin：50mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle. Receives: Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Pathological complete response (PCR) rate
Pathological complete response (PCR) rate
Measured: 2years
Secondary outcomes (3)
the rate of R0 resection
R0 resection rate
Measured: 2years
Disease free survival time
Disease free survival
Measured: 2years
1-year OS rate
1-year OS rate
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Apr 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Hong, Master, Principal investigator, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586242
- Sponsor's protocol ID
- TQXB-E-002
- Acronym
- EASOPCWAAC
- Status last verified
- Apr 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06586242
- Acronym / sponsor ID
- EASOPCWAAC / TQXB-E-002
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 19 Sep 2024 (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 a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.
Detailed description
The study was a two arm, randomized, prospective, multicenter study. The experimental group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin, and the control group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin | Experimental | Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatinpenpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week oxaliplatin：130mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle. |
| penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin | Active comparator | Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatinpenpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week lobaplatin：50mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. only those who meet all the following requirements can be enrolled in this trial: 1. age 18-75 years old, both male and female;
- 2. according to gastroscope / ultrasonic gastroscope biopsy, the pathology suggests esophageal cancer, and the clinical diagnosis is ct2n1-3m0 or ct3n0-3m0 or ct4n0-3m0, and the TNM stage is stage ii-iva;
- 3. patients with non cervical esophageal cancer;
- 4. have not received previous systemic and local treatment for esophageal cancer according to RECIST 1 1 criteria at least one measurable lesion was used for imaging evaluation of neoadjuvant therapy;
- 5.ecog PS: 0-1 point;
Key exclusion criteria (22 listed)
- 1. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- 2. patients with ulcerative esophageal squamous cell carcinoma;
- 3. patients with esophageal fistula or tracheal fistula;
- 4. those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
- 5. have a history of immune deficiency, including HIV positive or suffering from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
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 |
|---|---|---|
| Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatinAlso: AK105；AL3818200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, Penpulimab:administered on the first day of each cycle Anlotinib:Body weight <60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w | Drug | penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin, penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin |
Primary outcome
the Pathological complete response (PCR) rate
Time frame: 2years
Pathological complete response (PCR) rate
3 secondary outcomes
the rate of R0 resection
Time frame: 2years
Disease free survival time
Time frame: 2years
1-year OS rate
Time frame: 2years
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 19 Sep 2024.
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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.
Liu Hong, Master principal investigator
The First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin in people with Esophageal Cancer, run by Xijing Hospital 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 8 inclusion and 22 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 19 Sep 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 Liu Hong, Master (18792807591 ext. 0086-, 18792804403@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Pathological complete response (PCR) rate (time frame: 2years). 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 19 Sep 2024.