Esophageal Cancer by AJCC V8 StagePhase 2NCT05738434
Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC
A Phase 2 study testing Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib and Camrelizumab+Chemotherapy→Camrelizumab in people with Esophageal Cancer by AJCC V8 Stage, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer by AJCC V8 Stage
- What is being tested?
- Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib and Camrelizumab+Chemotherapy→Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2023to 1 Mar 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
- 1. Age 18-75, male or female;
- 2. Esophageal squamous cell carcinoma that is histologically or cytologically confirmed as unresectable locally advanced/recurrent (unable to receive radical treatment such as radical chemoradiotherapy or radical radiotherapy) or distant metastasis;
- 3. No previous systematic antitumor therapy. For patients who received neoadjuvant/adjuvant and radical concurrent chemoradiotherapy, the time from the last chemotherapy to recurrence or progression more than 6 months can be screened;
- 4. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there should be at least one measurable lesion (esophageal and other cavity structures cannot be used as measurable lesions), and the measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previous radiotherapy area can also be selected as target lesions if it is confirmed to progress);
- 5. Agree to provide tissue samples for biomarker (such as PD-L1) analysis. Recently obtained tissues are preferred. Patients who cannot provide recently obtained tissues can provide 5-8 paraffin sections of 3-5 μm thickness for archival storage;
- 6. ECOG PS: 0 ~ 1;
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- 7. Swallowing pills normally;
- 8. Expected survival ≥12 weeks;
- 9. The functions of vital organs meet the following requirements (no drugs with blood components and cell growth factors are allowed to be used within 14 days before the first use of the study drug);
- Absolute count of neutrophils (ANC) ≥1.5×109/L
- Platelet ≥90×109/L;
- Hemoglobin ≥90g/L;
- Serum albumin ≥28g/L;
- Total bilirubin ≤1.5 × ULN, ALT, AST, and/or AKP≤2.5 × ULN; If liver metastasis is present, ALT and/or AST≤5 × ULN; If there is liver metastasis or bone metastasis AKP≤5 × ULN;
- Serum creatinine ≤1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault);
- Activated partial thromboplastin time (APTT) and International Normalized ratio (INR) ≤1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the expected treatment range of anticoagulants can be screened)
- 10. Fertile female subjects and male subjects whose partners are women of childbearing age, A medically approved contraceptive (such as an intrauterine device, contraceptive or condom) is required during the study treatment period and at least 2 months after the last use of carrilizumab/Apatinib mesylate and at least 6 months after the last use of chemotherapy;
- 11. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- 1. BMI < 18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening (while the effect of large amounts of abdominal and thoracic fluids on body weight should be considered);
- 2. Active hemoptysis occurred within 3 weeks before the first administration of the study drug, or tumor hemorrhage occurred within 2 weeks before the first administration of the study intervention;
- 3. Patients with tumors assessed by the investigator to have invaded adjacent organs of the esophageal lesion (such as the aorta or respiratory tract) and had a high risk of bleeding or fistula during the study;
- 4. Previous history of gastrointestinal perforation and/or fistula or recent (within 3 months before randomization) history of intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
- 5. Subjects who have had esophageal stents implanted or are evaluated for needing esophageal stents implanted;
- 6. Patients with clinical symptoms of pleural effusion, pericardial effusion or ascites who need puncture or drainage or who have received drainage for treatment within 1 month before randomization;
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- 7. Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- 8. A history of allergies to monoclonal antibodies, any component of Camrelizumab, Apatinib mesylate and its excipients, paclitaxel, albumin paclitaxel and cisplatin;
- 9. Received any of the following medical treatment:
- Received any investigational drug within 4 weeks prior to initial use of the investigational drug;
- Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
- Receiving the last dose of anticancer therapy (including radiotherapy, etc.) within 4 weeks or less before the first use of the study drug;
- Subjects who required systemic treatment with corticosteroids (> 10 mg daily equivalent of prednisone) or other immunosuppressant within 2 weeks prior to initial use of the study drug, except for corticosteroids for local esophageal inflammation and prevention of allergy, nausea, and vomiting. In the absence of active autoimmune disease, inhaled or topical steroid and adrenocortical hormone replacement at doses > 10mg/ day of prednisone efficacy dose are permitted;
- Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the study drug;
- Major surgery or severe trauma within 4 weeks prior to initial use of the study drug;
- 10. The toxicity of previous antitumor therapy has not recovered to ≤CTCAE Grade 1 (except hair loss) or the level specified by inclusion/exclusion criteria;
- 11. Patients with central nervous system metastasis;
- 12. History of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaries, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for patients with vitiligo or asthma/allergies from childhood that have recovered and require no intervention as adults; Autoimmune mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type 1 diabetes using a steady dose of insulin;
- 13. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
- 14. Subjects have poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Grade II or higher heart failure, (2) unstable angina pectoris, (3) previous myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are not well controlled without clinical intervention or after clinical intervention;
- 15. Severe infections (CTCAE > Grade 2), such as severe pneumonia, bacteremia, and infection complications requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to initial use of the study drug, or the need for oral or intravenous antibiotic treatment, except for the use of prophylactic antibiotics;
- 16. History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia;
- 17. Patients with active tuberculosis infection identified by medical history or CT examination, or with a history of active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year ago but without formal treatment;
- 18. Subjects had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the assay limit);
- 19. Bleeding symptoms of significant clinical significance or definite bleeding tendency, such as digestive tract bleeding, hemorrhagic ulcer or vasculitis, have occurred within 3 months before randomization. If stool occult blood is positive in baseline period, review can be conducted; if it is still positive after review, combined with clinical judgment, gastroscopy should be performed if necessary;
- 20. Arteriovenous thrombosis events occurring within 6 months prior to randomization, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Superficial vein thrombosis could be included after being determined by the researchers;
- 21. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. haemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- 22. With active ulcers, unhealed wounds or with fractures;
- 23. Urine routine indicated urinary protein ≥ ++ and confirmed 24-hour urinary protein volume \> 1.0g;
- 24. Subjects were still using a strong CYP3A4 inducer within 2 weeks before randomization, or were still using a strong CYP3A4 inhibitor within 1 week before randomization;
- 25. Any other malignancies diagnosed within five years prior to the first use of the study drug, other than those with a low risk of metastasis and death (5-year survival > 90%), such as basal or squamous cell skin cancer or carcinoma in situ of the cervix after adequate treatment;
- 26. Pregnant or lactating women;
- 27. In the investigator's judgment, the subjects had other factors that might have led to their being forced to terminate the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the subjects' safety or the circumstances in which the study data were collected.
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 Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, phD, 13938244776, fengw010@163.com
About this study
Official title: A Randomized, Controlled, Multicenter Clinical Study of Camrelizumab in Combination With Apatinib Mesylate and Chemotherapy Versus Camrelizumab Plus Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line
- Conditions
- Esophageal Cancer by AJCC V8 Stage
- Being tested
- Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib, Camrelizumab+Chemotherapy→Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+ApatinibDrug
camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investigator' choice： paclitaxel 135~150 mg/m2, i.v. d1,q3w; paclitaxel-albumin 150~180 mg/m2, i.v. d1,q3w. up to 4 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w
Camrelizumab+Chemotherapy→CamrelizumabDrug
camrelizumab 200 mg, i.v. d1,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investgator' choice： paclitaxel 175 mg/m2, i.v. d1,q3w; paclitaxel-albumin 200 mg/m2, i.v. d1,q3w up to 6 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w;
| Study group | Role | What they receive |
|---|---|---|
| Short-course Chemotherapy | Experimental | Not described Receives: Drug: Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib |
| Chemotherapy | Active comparator | Not described Receives: Drug: Camrelizumab+Chemotherapy→Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS[Progression-Free Survival]
Time from randomization to first radiographic disease progression (RECIST 1.1 criteria) or death, whichever occurs first.
Measured: up to 2 year
Secondary outcomes (6)
OS[Overall Survival]
Time from randomization 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: up to 2 year
ORR[Objective Response Rate]
Proportion of subjects in the analysis population who achieved complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Measured: up to 1 year
DCR[Disease Control Rate]
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: up to 1 year
TTR[Time to response]
Time from randomization to firstly achieve CR or PR based on RECIST 1.1 criteria.
Measured: up to 1 year
DoR[Duration of response]
For subjects who achieved remission, the time from first achieving CR or PR to disease progression or death, whichever occurred earlier.
Measured: up to 2 year
AEs[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: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start2 Mar 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer by AJCC V8 StageStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Feng Wang, phD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738434
- Sponsor's protocol ID
- MA-EC-II-014
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Clinical Study of Camrelizumab in Combination With Apatinib Mesylate and Chemotherapy Versus Camrelizumab Plus Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05738434
- Acronym / sponsor ID
- MA-EC-II-014
- Conditions
- Esophageal Cancer by AJCC V8 Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Feb 2023 (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.
To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-course Chemotherapy | Experimental | Drug: Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib |
| Chemotherapy | Active comparator | Drug: Camrelizumab+Chemotherapy→Camrelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. Age 18-75, male or female;
- 2. Esophageal squamous cell carcinoma that is histologically or cytologically confirmed as unresectable locally advanced/recurrent (unable to receive radical treatment such as radical chemoradiotherapy or radical radiotherapy) or distant metastasis;
- 3. No previous systematic antitumor therapy. For patients who received neoadjuvant/adjuvant and radical concurrent chemoradiotherapy, the time from the last chemotherapy to recurrence or progression more than 6 months can be screened;
- 4. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there should be at least one measurable lesion (esophageal and other cavity structures cannot be used as measurable lesions), and the measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previous radiotherapy area can also be selected as target lesions if it is confirmed to progress);
- 5. Agree to provide tissue samples for biomarker (such as PD-L1) analysis. Recently obtained tissues are preferred. Patients who cannot provide recently obtained tissues can provide 5-8 paraffin sections of 3-5 μm thickness for archival storage;
Key exclusion criteria (33 listed)
- 1. BMI < 18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening (while the effect of large amounts of abdominal and thoracic fluids on body weight should be considered);
- 2. Active hemoptysis occurred within 3 weeks before the first administration of the study drug, or tumor hemorrhage occurred within 2 weeks before the first administration of the study intervention;
- 3. Patients with tumors assessed by the investigator to have invaded adjacent organs of the esophageal lesion (such as the aorta or respiratory tract) and had a high risk of bleeding or fistula during the study;
- 4. Previous history of gastrointestinal perforation and/or fistula or recent (within 3 months before randomization) history of intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
- 5. Subjects who have had esophageal stents implanted or are evaluated for needing esophageal stents implanted;
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 |
|---|---|---|
| Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinibcamrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investigator' choice： paclitaxel 135~150 mg/m2, i.v. d1,q3w; paclitaxel-albumin 150~180 mg/m2, i.v. d1,q3w. up to 4 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w | Drug | Short-course Chemotherapy |
| Camrelizumab+Chemotherapy→Camrelizumabcamrelizumab 200 mg, i.v. d1,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investgator' choice： paclitaxel 175 mg/m2, i.v. d1,q3w; paclitaxel-albumin 200 mg/m2, i.v. d1,q3w up to 6 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w; | Drug | Chemotherapy |
Primary outcome
PFS[Progression-Free Survival]
Time frame: up to 2 year
Time from randomization to first radiographic disease progression (RECIST 1.1 criteria) or death, whichever occurs first.
6 secondary outcomes
OS[Overall Survival]
Time frame: up to 2 year
ORR[Objective Response Rate]
Time frame: up to 1 year
DCR[Disease Control Rate]
Time frame: up to 1 year
TTR[Time to response]
Time frame: up to 1 year
DoR[Duration of response]
Time frame: up to 2 year
AEs[Adverse events]
Time frame: up to 2 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 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Feng Wang, phD principal investigator
The First Affiliated Hospital of Zhengzhou 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 Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib and Camrelizumab+Chemotherapy→Camrelizumab in people with Esophageal Cancer by AJCC V8 Stage, run by The First Affiliated Hospital of Zhengzhou 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 33 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 21 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 Feng Wang, phD (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS[Progression-Free Survival] (time frame: up to 2 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 21 Nov 2024.