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New treatment option for Esophageal Cancer
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
What this study is testing
What is Apatinib+ SHR-1210（Camrelizumab）?
Apatinib+ SHR-1210（Camrelizumab） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- First-line patients who progressed or were intolerant after chemotherapy (cohort A) or immumotherapy (other cohorts). Concurrent chemoradiotherapy...
- 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...
You likely can't join if
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis...
- Patients receiving prior radiation therapy must not have developed radiation pneumonia, have recovered from all radiation-related toxicities, and do...
- Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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;
- 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...
- 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 people...
- All people 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.
- 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...
- 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;
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.