Stage IV Esophagus Squamous Cell CarcinomaPhase 2NCT05322499
Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Advanced Esophageal Squamous Cell Cancer
A Phase 2 study testing Camrelizumab, Irinotecan and Paclitaxel in people with Stage IV Esophagus Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Esophagus Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab, Irinotecan and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2022to 15 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-75 years old, male or female;
- Participants signed and dated written informed consent. (Informed consent forms must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care.);
- Patients with advanced esophageal squamous cell carcinoma diagnosed as stage IV by histopathology or cytology;
- ECOG PS score of physical condition: 0-1 points;
- Expected survival period ≥ 3 months;
- Patients with esophageal squamous cell carcinoma who have received first-line or above systemic therapy in the past, and who have received at least 2 times of PD-1 immunotherapy;
- Laboratory inspection indicators meet the following requirements:
- Bone marrow function: hemoglobin (Hb) ≥ 90g/L; white blood cell count (WBC) ≥ lower limit of normal; absolute neutrophil value (ANC) ≥ 1.5×10^9 /L; platelet count ≥ 100×10^9 / L; (2) Renal function: Cr≤UNL (upper limit of normal)×1.5, endogenous creatinine clearance rate (Ccr)≥55 ml/min; (3) Liver function: total bilirubin≤ULN×1.5; ALT and AST≤ULN×2.5; (4) Coagulation function: the international normalized ratio of prothrombin time is less than or equal to ULN×1.5, and the partial thromboplastin time is within the normal range; 8. Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before the study is enrolled, and non-lactating patients; males agree to use contraception during the study period and within 6 months after the end of the study contraceptive patients; 9. Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment; 10. Patients with good compliance are expected to be able to follow up the efficacy and adverse reactions according to the requirements of the program; 11. In view of the unclear definition of primary drug resistance and the lack of standard treatment options for such patients, there is a potential possibility of benefiting such patients with immunization combined with anti-angiogenesis or chemotherapy, but there is also a certain risk of hyperprogression; Therefore, for patients with possible primary drug resistance, they must be included in the group after evaluation by the investigator.
Who cannot join
- Other malignant tumors have been diagnosed in the past 5 years;
- Patients with active bleeding within two months of the primary tumor;
- Patients with severe adverse reactions related to immunotherapy after previous use of immunotherapy;
- Patients with any active autoimmune disease or autoimmune disease (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vascular inflammation, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type 1 diabetes mellitus receiving stable doses of insulin, hypothyroidism receiving only hormone replacement therapy, no systemic therapy required, and no acute exacerbation of skin disease (eg, eczema, vitiligo, or psoriasis) within 1 year prior to the screening period. );
- Suffering from uncontrolled clinical symptoms or diseases of the heart;
- Active infection or fever (except for definite tumor fever);
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- History or evidence of interstitial lung disease or active non-infectious pneumonia;
- Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before the study is enrolled, and non-lactating patients; males agree to use contraception during the study period and within 6 months after the end of the study contraceptive patients;
- Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment;
- Patients with good compliance are expected to be able to follow up the efficacy and adverse reactions according to the requirements of the program;
- In view of the unclear definition of primary drug resistance and the lack of standard treatment options for such patients, there is a potential possibility of benefiting such patients with immunization combined with anti-angiogenesis or chemotherapy, but there is also a certain risk of hyperprogression; Therefore, for patients with possible primary drug resistance, they must be included in the group after evaluation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Second-line or Above Therapy for Advanced Esophageal Squamous Cell Cancer Previously Treated With First-line Immunotherapy
To observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy
Read the detailed description
How to improve the efficacy of immunotherapy, evaluate the results of immunotherapy more objectively, and overcome immune resistance through reasonable combined treatment methods, so as to maximize the benefit of patients from immunotherapy, is an urgent research direction to be explored. Therefore, this study intends to observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell cancer previously Treated With First-line Immunotherapy . It can provide a basis for the treatment of esophageal cancer after immune resistance.
- Being tested
- Camrelizumab, Irinotecan, Paclitaxel, Paclitaxel-albumin, Docetaxel
- 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.
CamrelizumabDrug
Also called SHR-1210
200mg/dose intravenous infusion, D1, once every 3 weeks (q3w);
IrinotecanDrug
100-125mg/m2，d1，d8；q21d
PaclitaxelDrug
135-175mg/m2，d1，Q3W
Paclitaxel-albuminDrug
100-135mg/m2, d1、d8，Q3W
DocetaxelDrug
60-75mg/m2，d1，Q3W
AnlotinibDrug
12mg，qd，d1-d14，q3w
| Study group | Role | What they receive |
|---|---|---|
| Combined chemotherapy group | Experimental | Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w);
Chemotherapy (considered by investigator on a patient-by-patient basis):
Irinotecan: 100-125mg/m2, d1, d8; q21d; Paclitaxel: 135-175mg/m2, d1, Q3W; Docetaxel: 60-75mg/m2, d1, Q3W Albumin paclitaxel: 100-135mg/m2, d1, d8, Q3W. Treat until disease progression or intolerable toxicity Receives: Drug: Camrelizumab; Drug: Irinotecan; Drug: Paclitaxel; Drug: Paclitaxel-albumin; Drug: Docetaxel |
| Combined anlotinib group | Experimental | Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Anlotinib: 12mg, qd, d1-d14, q3w; Treat until disease progression or intolerable toxicity. Receives: Drug: Camrelizumab; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Up to 24 month
Secondary outcomes (4)
Duration of response (DoR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to 24 month
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
Measured: Up to 24 month
Progression-free survival (PFS)
Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause
Measured: Up to 24 month
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Measured: Up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Esophagus Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Xinmin, Zhejiang Cancer Hospital
- Investigators
- Xinmin Yu, Doctor, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322499
- Sponsor's protocol ID
- IRB-2021-444
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2022
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Second-line or Above Therapy for Advanced Esophageal Squamous Cell Cancer Previously Treated With First-line Immunotherapy
- ClinicalTrials.gov ID
- NCT05322499
- Acronym / sponsor ID
- IRB-2021-444
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 11 Apr 2022 (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 observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy
Detailed description
How to improve the efficacy of immunotherapy, evaluate the results of immunotherapy more objectively, and overcome immune resistance through reasonable combined treatment methods, so as to maximize the benefit of patients from immunotherapy, is an urgent research direction to be explored. Therefore, this study intends to observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell cancer previously Treated With First-line Immunotherapy . It can provide a basis for the treatment of esophageal cancer after immune resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined chemotherapy group | Experimental | Drug: Camrelizumab, Drug: Irinotecan, Drug: Paclitaxel, Drug: Paclitaxel-albumin, Drug: DocetaxelCamrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Chemotherapy (considered by investigator on a patient-by-patient basis): Irinotecan: 100-125mg/m2, d1, d8; q21d; Paclitaxel: 135-175mg/m2, d1, Q3W; Docetaxel: 60-75mg/m2, d1, Q3W Albumin paclitaxel: 100-135mg/m2, d1, d8, Q3W. Treat until disease progression or intolerable toxicity |
| Combined anlotinib group | Experimental | Drug: Camrelizumab, Drug: AnlotinibCamrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Anlotinib: 12mg, qd, d1-d14, q3w; Treat until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old, male or female;
- Participants signed and dated written informed consent. (Informed consent forms must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care.);
- Patients with advanced esophageal squamous cell carcinoma diagnosed as stage IV by histopathology or cytology;
- ECOG PS score of physical condition: 0-1 points;
- Expected survival period ≥ 3 months;
Key exclusion criteria (11 listed)
- Other malignant tumors have been diagnosed in the past 5 years;
- Patients with active bleeding within two months of the primary tumor;
- Patients with severe adverse reactions related to immunotherapy after previous use of immunotherapy;
- Patients with any active autoimmune disease or autoimmune disease (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vascular inflammation, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type 1 diabetes mellitus receiving stable doses of insulin, hypothyroidism receiving only hormone replacement therapy, no systemic therapy required, and no acute exacerbation of skin disease (eg, eczema, vitiligo, or psoriasis) within 1 year prior to the screening period. );
- Suffering from uncontrolled clinical symptoms or diseases of the heart;
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210200mg/dose intravenous infusion, D1, once every 3 weeks (q3w); | Drug | Combined anlotinib group, Combined chemotherapy group |
| Irinotecan100-125mg/m2，d1，d8；q21d | Drug | Combined chemotherapy group |
| Paclitaxel135-175mg/m2，d1，Q3W | Drug | Combined chemotherapy group |
| Paclitaxel-albumin100-135mg/m2, d1、d8，Q3W | Drug | Combined chemotherapy group |
| Docetaxel60-75mg/m2，d1，Q3W | Drug | Combined chemotherapy group |
| Anlotinib12mg，qd，d1-d14，q3w | Drug | Combined anlotinib group |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 24 month
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
4 secondary outcomes
Duration of response (DoR)
Time frame: Up to 24 month
Disease control rate (DCR)
Time frame: Up to 24 month
Progression-free survival (PFS)
Time frame: Up to 24 month
Overall survival (OS)
Time frame: Up to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- 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. This study is not recruiting at the moment.
Xinmin Yu, Doctor principal investigator
Zhejiang Cancer Hospital
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, Irinotecan and Paclitaxel in people with Stage IV Esophagus Squamous Cell Carcinoma, run by Zhejiang Cancer 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 11 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinmin Yu, MD (13705718617, yuxm@zjcc.org.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 24 month). 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 11 Apr 2022.