Esophageal CancerPhase 2NCT03736863
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Apatinib+ SHR-1210（Camrelizumab）, Apatinib+ SHR-1316（Adebrelimab） and SHR-1316（Adebrelimab）+SHR-A2009 in people with Esophageal Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of multiple drug combinations in the treatment of advanced esophageal squamous cell carcinoma. 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?
- Apatinib+ SHR-1210（Camrelizumab）, Apatinib+ SHR-1316（Adebrelimab） and SHR-1316（Adebrelimab）+SHR-A2009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2019to 30 Dec 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
- Aged 18-75 years, males or females;
- Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant metastases;
- First-line patients who progressed or were intolerant after chemotherapy (cohort A) or immumotherapy (other cohorts). Concurrent chemoradiotherapy with postoperative recurrence or metastasis is considered as first-line treatment. For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, it should be counted as first-line treatment failure;
- The best overall response of first-line immunotherapy is CR, PR or SD, and PFS ≥ 3 months;
- According to the Response Evaluation Criteria In Solid Tumour (RECIST 1.1), there is at least one measurable lesion, which has not received any local treatment, such as radiotherapy (if the lesion within the region of the previous radiotherapy is confirmed to progress and satisfies RECIST1.1, it can be also selected as the target lesion) ;
- Tissue samples should be provided for biomarker analysis. The newly harvested tissues are preferred. If the newly harvested tissues are not available, 5-8 archival paraffin sections (5 um thick) can be provided;
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- ECOG: 0~1;
- Expected survival time ≥ 12 weeks;
- Adequate function of major organs defined as:(1) Routine blood test: a. HB ≥ 90 g/L; b. ANC ≥ 1.5 × 109/L; c. PLT ≥ 80 × 109/L;(2) Biochemical test: a. ALB ≥ 30 g/L; b. ALT and AST ≤ 2.5 ULN; if there is no liver metastasis, ALT and AST ≤ 5 ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5 ULN or creatinine clearance rate (CCr) ≥ 60 mL/min;
- Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- Women of childbearing age should consent to take contraception measures during the study period and within 6 months after the end of the study (eg., intrauterine device, oral contraceptive pills or condoms). The subjects must be negative for the serum or urine pregnancy test within 7 days before the recruitment. The female subjects must be non-lactating women. Males should consent to take contraception measures during the study period and within 6 months after the end of the study;
- All subjects are recruited on a voluntary basis and sign the informed consent. They are required to be compliant with the study and cooperative with the follow-up.
Who cannot join
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis); Hyperthyroidism; vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators were not included; Grade 3 or above immune-related adverse events occurred during previous treatment;
- Patients receiving prior radiation therapy must not have developed radiation pneumonia, have recovered from all radiation-related toxicities, and do not require corticosteroid treatment;
- Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
- ESCC patients with active bleeding in primary lesions;
- Those who have received the same type of drug as the drug in this study (except immune checkpoint inhibitors);
- If the investigational drug is taken orally, patients with multiple factors affecting the oral drug (such as inability to swallow, post-GI resection, chronic diarrhea, and intestinal obstruction) are excluded;
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- Brain metastasis or brain metastases that have disappeared in less than 3 months;
- Patients who have any severe and/or uncontrolled diseases, including: poor blood pressure control (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 100 mmHg); having myocardial ischemia or myocardial infarction and arrhythmia of Grade 1 and above (including QT interval ≥ 480 ms) and cardiac insufficiency of Grade 1; active or uncontrollable severe infection; liver diseases, such as decompensated liver failure, active hepatitis B (HBV-DNA ≥ 104 copy number/mL or 2000 IU/mL) or hepatitis C (positive for anti-HCV antibodies, and HCV-RNA higher than the lower limit of detection with the analytical method); routine urine test indicates urine protein ≥++ and confirms that the 24-hour urinary protein quantification>1.0 g;
- Patients whose wounds or bone fractures remain unhealed for a long period of time;
- Pneumorrhagia \> NCI-CTC AE Grade1 within four weeks before recruitment; bleeding at other positions \>NCI-CTC AE Grade 2 within four weeks before recruitment; having a bleeding tendency (eg., active peptic ulcer) or currently receiving thrombolytic or anticoagulant therapy, such as warfarin, heparin, or their analogs;
- Patients who have experienced arterial/venous thrombotic events within six months, such as cerebrovascular accidents (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;
- The invasion of important blood vessels by the tumour or a high probability of the invasion of important blood vessels by the tumor that may lead to lethal hemorrhage in the study period ahead, as judged by the investigator according to the radiological examination;
- Pregnancy or lactation;
- Patients who have a history of other malignancies in the past five years (except for the cured basal cell carcinoma and cervical carcinoma in situ);
- Patients who have a history of psychotropic drug abuse and unable to quit or having mental disorders;
- Patients who have participated in other clinical trials of drugs in the past four weeks;
- Patients who have concomitant diseases that may severely impair the safety of patients or make the patients unable to complete the study, as judged by the investigator;
- Other patients who are considered inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, doctor
About this study
The purpose of this study is to observe and evaluate the efficacy and safety of multiple drug combinations in the treatment of advanced esophageal squamous cell carcinoma.
Read the detailed description
Immunotherapy has been widely used in patients with advanced esophageal cancer. Immunochemotherapy has become the standard treatment for advanced esophageal squamous cell carcinoma. The common second-line standard treatment is immunotherapy or chemotherapy, but that are established according to the medical evidence after the progression of chemotherapy, the preferred treatment plan after immuno-resistance needs to be explored. The purpose of this study was to explore the efficacy and safety of different drug combinations in patients with advanced esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Apatinib+ SHR-1210（Camrelizumab）, Apatinib+ SHR-1316（Adebrelimab）, SHR-1316（Adebrelimab）+SHR-A2009
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib+ SHR-1210（Camrelizumab）Drug
Apatinib 250mg, q.d.po+SHR-1210（Camrelizumab）200 mg，Intravenous injection，q2W
Apatinib+ SHR-1316（Adebrelimab）Drug
Apatinib 250mg, q.d.po+SHR-1316（Adebrelimab） 1200 mg，Intravenous injection，q2W
SHR-1316（Adebrelimab）+SHR-A2009Drug
SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W,
| Study group | Role | What they receive |
|---|---|---|
| CohortA：Apatinib+SHR-1210（Camrelizumab） | Experimental | Apatinib+SHR-1210（Camrelizumab）for ESCC who progressed or were intolerant to first-line systemic chemotherapy Receives: Drug: Apatinib+ SHR-1210（Camrelizumab） |
| CohortB：Apatinib+SHR-1210（Camrelizumab） | Experimental | Apatinib+SHR-1210（Camrelizumab）for ESCC who have failed prior immune checkpoint inhibitor therapies Receives: Drug: Apatinib+ SHR-1210（Camrelizumab） |
| CohortC：Apatinib+SHR-1316（Adebrelimab） | Experimental | Apatinib+SHR-1316（Adebrelimab）for ESCC who have failed prior immune checkpoint inhibitor therapies Receives: Drug: Apatinib+ SHR-1316（Adebrelimab） |
| CohortD：SHR-1316（Adebrelimab）+SHR-A2009 | Experimental | SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W, for ESCC who have failed prior immune checkpoint inhibitor therapies. Receives: Drug: SHR-1316（Adebrelimab）+SHR-A2009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 1 year
Secondary outcomes (8)
Disease Control Rate (DCR)
the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR
+ PR + SD)
Measured: up to 1 year
Progression-free Survival (PFS)
the time from treatment initiation to the first disease progression or death from any cause
Measured: up to 2 year
Duration of response（DOR）
the time from the first confirmed response date to the first disease progression or death date
Measured: up to 2 year
Time to response（TTP）
the time from treatment to first confirmed tumour response
Measured: up to 1 year
Overall survival(OS)
the time from treatment initiation until death from any reason
Measured: up to 2 year
3- and 6-month PFS rates
Progression-free survival rates at 3- and 6-month
Measured: up to 6 months
6-, 9- and 12-month OS rates
overall survival rates at 6-, 9- and 12-month
Measured: up to 12 months
adverse events(Safety)
adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start5 Dec 2019
- Primary completion20 Jun 2021
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 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, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736863
- Sponsor's protocol ID
- FQX-001/MA-EC-II-002/CAP 02
- Status last verified
- Sep 2024
- First submitted
- 8 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng X, Wu T, Hong Y, Fan Q, Ren Z, Guo Y, Yang X, Shi P, Yang J, Yin X, Luo Z, Xia J, Zhou Y, Xu M, Liu E, Jiang G, Li S, Zhao F, Ma C, Ma C, Hou Z, Li J, Wang J, Wang F. Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):245-253. doi: 10.1016/S2468-1253(21)00378-2. Epub 2022 Jan 6.
PubMed 34998471
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 Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03736863
- Acronym / sponsor ID
- FQX-001/MA-EC-II-002/CAP 02
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Nov 2018 (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.
The purpose of this study is to observe and evaluate the efficacy and safety of multiple drug combinations in the treatment of advanced esophageal squamous cell carcinoma.
Detailed description
Immunotherapy has been widely used in patients with advanced esophageal cancer. Immunochemotherapy has become the standard treatment for advanced esophageal squamous cell carcinoma. The common second-line standard treatment is immunotherapy or chemotherapy, but that are established according to the medical evidence after the progression of chemotherapy, the preferred treatment plan after immuno-resistance needs to be explored. The purpose of this study was to explore the efficacy and safety of different drug combinations in patients with advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CohortA：Apatinib+SHR-1210（Camrelizumab） | Experimental | Drug: Apatinib+ SHR-1210（Camrelizumab）Apatinib+SHR-1210（Camrelizumab）for ESCC who progressed or were intolerant to first-line systemic chemotherapy |
| CohortB：Apatinib+SHR-1210（Camrelizumab） | Experimental | Drug: Apatinib+ SHR-1210（Camrelizumab）Apatinib+SHR-1210（Camrelizumab）for ESCC who have failed prior immune checkpoint inhibitor therapies |
| CohortC：Apatinib+SHR-1316（Adebrelimab） | Experimental | Drug: Apatinib+ SHR-1316（Adebrelimab）Apatinib+SHR-1316（Adebrelimab）for ESCC who have failed prior immune checkpoint inhibitor therapies |
| CohortD：SHR-1316（Adebrelimab）+SHR-A2009 | Experimental | Drug: SHR-1316（Adebrelimab）+SHR-A2009SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W, for ESCC who have failed prior immune checkpoint inhibitor therapies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18-75 years, males or females;
- Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant metastases;
- First-line patients who progressed or were intolerant after chemotherapy (cohort A) or immumotherapy (other cohorts). Concurrent chemoradiotherapy with postoperative recurrence or metastasis is considered as first-line treatment. For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, it should be counted as first-line treatment failure;
- The best overall response of first-line immunotherapy is CR, PR or SD, and PFS ≥ 3 months;
- According to the Response Evaluation Criteria In Solid Tumour (RECIST 1.1), there is at least one measurable lesion, which has not received any local treatment, such as radiotherapy (if the lesion within the region of the previous radiotherapy is confirmed to progress and satisfies RECIST1.1, it can be also selected as the target lesion) ;
Key exclusion criteria (18 listed)
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis); Hyperthyroidism; vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators were not included; Grade 3 or above immune-related adverse events occurred during previous treatment;
- Patients receiving prior radiation therapy must not have developed radiation pneumonia, have recovered from all radiation-related toxicities, and do not require corticosteroid treatment;
- Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
- ESCC patients with active bleeding in primary lesions;
- Those who have received the same type of drug as the drug in this study (except immune checkpoint inhibitors);
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 |
|---|---|---|
| Apatinib+ SHR-1210（Camrelizumab）Apatinib 250mg, q.d.po+SHR-1210（Camrelizumab）200 mg，Intravenous injection，q2W | Drug | CohortA：Apatinib+SHR-1210（Camrelizumab）, CohortB：Apatinib+SHR-1210（Camrelizumab） |
| Apatinib+ SHR-1316（Adebrelimab）Apatinib 250mg, q.d.po+SHR-1316（Adebrelimab） 1200 mg，Intravenous injection，q2W | Drug | CohortC：Apatinib+SHR-1316（Adebrelimab） |
| SHR-1316（Adebrelimab）+SHR-A2009SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W, | Drug | CohortD：SHR-1316（Adebrelimab）+SHR-A2009 |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 1 year
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
8 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 1 year
Progression-free Survival (PFS)
Time frame: up to 2 year
Duration of response（DOR）
Time frame: up to 2 year
Time to response（TTP）
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 2 year
3- and 6-month PFS rates
Time frame: up to 6 months
6-, 9- and 12-month OS rates
Time frame: up to 12 months
adverse events(Safety)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 34998471Meng X, Wu T, Hong Y, Fan Q, Ren Z, Guo Y, Yang X, Shi P, Yang J, Yin X, Luo Z, Xia J, Zhou Y, Xu M, Liu E, Jiang G, Li S, Zhao F, Ma C, Ma C, Hou Z, Li J, Wang J, Wang F. Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):245-253. doi: 10.1016/S2468-1253(21)00378-2. Epub 2022 Jan 6.
- 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.
Feng Wang 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 Apatinib+ SHR-1210（Camrelizumab）, Apatinib+ SHR-1316（Adebrelimab） and SHR-1316（Adebrelimab）+SHR-A2009 in people with Esophageal Cancer, 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 12 inclusion and 18 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (13938244776, fengw010@163.com), 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 1 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 NCT03736863, which also lists 1 linked publication.
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.