Clinical trial: NCT04168944
Section: Alternatives
Subsections: Alternative Procedures

| Shanghai Jiaotong University   |
|--------------------------------|
| School of Medicine, Renji      |
| Hospital Ethics Committee      |
| Approved 8 Aug 2019            |  
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You may choose not to participate in this study. If you do not want to take part in the study, there are other choices such as closely monitoring, other new drugs, chemotherapy, etc. You may discuss these options with your doctor.  
PERSON TO **CONTACT**
If you have questions, complaints or concerns about this study and you may have been injured from being in this study, you can contact Dr. Qiang Xia at +8615921197267. Institutional Review Board: Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The Renji hospital IRB may be reached by phone at (86)021-68383364 or by e-mail at rjllb3364@163.com Research Participant Advocate: You may also contact the Research Participant Advocate (RPA) by phone at +8615021628183 or by email at hanyongsun@163.com RESEARCH-RELATED **INJURY**
If you is injured from being in this study, medical care is available at the Renji hospital, as it is to all sick or injured people. The Renji hospital has not set aside any money to pay the costs for such care. The Renji hospital will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance). Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research.  
The Renji hopital is a public hospital. If you is injured in this study, and you want to sue the Renji hospital or the doctors, nurses, students, or other people who work for the hospital, special laws may apply. The Shanghai medical association is a law that controls when a person needs to bring a claim against the hospital. Please refer to the regulations on the "Revention and Management of Medical Disputes" of China.  
VOLUNTARY **PARTICIPATION** If you decide to take part in this study you are still free to withdraw at any time and without giving a reason. Refusal to participate or the decision to withdraw from this study will involve no penalty or loss of benefits to yours is otherwise entitled. If youdoesn't take part, you can still receive all standard care that is available to you. This will not affect the relationship you has with your doctor or other staff, nor decrease the standard of care that you receives as a patient. If you decide to withdrawal from being in this study, please let the research doctor know. That way you can find out what should be done about your routine care outside of the study. RIGHT OF INVESTIGATOR TO WITHDRAW **PARTICIPANTS** The investigator can withdraw you without your approval. Possible reasons for withdrawal include noncompliance with treatment, noncompliance with follow-up, etc.  
Shanghai Jiaotong University  
School of Medicine, Renji  
Hospital Ethics Committee  
Approved 8 Aug 2019  
COSTS AND COMPENSATION TO **PARTICIPANTS** All costs associated with this study will be billed to you or your insurance company in the ordinary manner.  
In case of injury related to this study, corresponding economic compensation will be given according to national laws and regulations.  
NEW **INFORMATION**
Sometimes during the course of a research project, new information becomes available about the lenvatinib that is being studied. If this happens, your child's research doctor will tell you about it and discuss with you whether you want your child to continue in the study.  
NUMBER OF **PARTICIPANTS**
We expect to enroll 106 participants at the Renji hospital.  
AUTHORIZATION FOR USE OF YOUR CHILD'S PROTECTED HEALTH **INFORMATION**
Signing this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study. This is the information we will use and include in our research records:  
- Demographic and identifying information like name, address telephone number, and email address
- Related medical information about yours like family medical history, allergies, current and past medications or therapies, and information from physical examinations, such as blood pressure reading, heart rate, temperature, and lab results
- All tests and procedures that will be done in the study
Clinical trial: NCT04168944
Section: Confidentiality
Subsections: How We Will Protect And Share Your Information:

- We will do everything we can to keep your information private but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law.  
- A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not include information that can identify your child. At most, the website  
Shanghai Jiaotong University  
School of Medicine, Renji  
Hospital Ethics Committee  
Approved 8 Aug 2019  
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will include a summary of the results. You can search this website at any time.  
- In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
o Members of the research team; o The Renji Hospital Ethics Committee, which reviews research involving people to make sure the study protects your rights; - If we share your information with groups outside of Renji hospital, we will not share your child's name or identifying information. We will label your child's information with a code number, so they will not know your child's identity. - If you do not want us to use information about your health, you should not agree to allow your child to be part of this research. If you choose not to participate, you can still receive health care services at Renji hospital.
Clinical trial: NCT04168944
Section: Withdrawal from Study
Subsections: What If I Decide To Not Participate After I Sign The Consent And Authorization Form?

You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able to collect new information about yours, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research.  
This authorization does not have an expiration date.  
CONSENT: I confirm that I have read this document and have had the opportunity to ask questions. I will be given a signed copy of the informed consent form to keep.  
I agree to participate in this research study and authorize you to use and disclose health information about mine for this study, as you have explained in this **document.**  
__________________________________ ____________ Participant's Signature Date  
  
Shanghai Jiaotong University  
  
School of Medicine, Renji  
Hospital Ethics Committee  
Approved 8 Aug 2019  
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WITNESS **STATEMENT:** The participant was unable to read or sign this consent form because of the following reason:
The participant is illiterate The participant is visually impaired The participant is physically unable to sign the consent form. Please describe:
Other (please *specify)*:
I confirm that I was present as a witness for the consent process for this study. I confirm that the participant named above was read the information in the consent document and that the participant has agreed to take part in the research study.  
______________________________________ Name of Witness
_______________________________________ _____________
Signature of Witness Date  
Shanghai Jiaotong University  
School of Medicine, Renji  
Hospital Ethics Committee  
Approved 8 Aug 2019