New anti-tumor drugs include drugs with potential application value obtained from animals, plants, bacteria, fungi and other substances, as well as natural products or chemically synthesized or recombinant new compounds or protein substances that can cause harm.

China's new drug approval measures stipulate that new drugs are drugs that have not been produced in China, and also include adding new indications, changing the route of administration and changing the dosage form of drugs that have already been produced.

New drugs must go through prescribed procedures such as basic research, animal testing, and human clinical trials before they can be marketed.

In clinical trials, researchers conduct trials of new drugs and treatment methods on subjects through active intervention or no intervention at all, and then obtain relevant information through data analysis and symptom observation.

For each new drug to be marketed, no matter how many in vitro and animal tests it undergoes, clinical trials in humans are still required to finalize the efficacy and safety of the drug.

By strictly following the Good Clinical Practice (GCP), the drug clinical trial process can be standardized, the results are scientific and reliable, and the rights and interests of subjects are protected and their safety is guaranteed.

Cancer chemotherapy drugs have a history of more than 70 years, and in these more than 70 years, it is the continuous research and application of new anti-tumor drugs that have enabled many tumors that were thought to be incurable in the past, such as childhood acute leukemia, chorioepithelial carcinoma, and some lymphomas, to be cured after chemotherapy, and the lives of a small number of advanced tumor patients have been significantly prolonged.

For example, for advanced breast cancer, conventional cyclophosphamide + methotrexate + 5-fluorouracil (CMF) or cyclophosphamide + doxorubicin + 5-fluorouracil (CAF) regimen chemotherapy is used, with an effective rate of 30%~60%.

Due to the emergence of the new anti-tumor drugs paclitaxel, Tysotete and norvinblastine, the effective rate of monotherapy is 60%, and the effective rate of combination with doxorubicin is 80%, which significantly improves the efficacy.

For example, new drugs such as uranium osali and Cape Tuo for advanced colorectal cancer have also significantly improved their efficacy. In recent years, new targeted therapy drugs have specifically bound to molecular targets on the surface or inside tumor cells when they enter the human body, causing specific death of tumor cells.

These drugs are used alone or in combination with chemotherapy to greatly improve the treatment effect of lung adenocarcinoma, colorectal cancer, malignant melanoma and other tumors.

However, there are still some tumors that have unsatisfactory drug treatment effects, and some tumors (such as high-grade lymphoma) are effective against many drugs at the beginning of treatment, but the tumor is quickly resistant to drugs during treatment, resulting in treatment failure.

All of these require us to continue to research, develop, and apply new drugs, and apply reasonable combination drug regimens to improve efficacy and overcome drug resistance.

The trial of new anti-tumor drugs often selects patients whose disease has progressed after failure or effectiveness of conventional drug therapy, or some diseases that have poor current drug treatment effects.

There is currently no better treatment for these patients or diseases, and it is possible to benefit from participating in clinical trials of new drugs and applying new drugs or new treatment options.

Drug clinical trials are carried out on the premise that they do not harm the interests of patients and may bring benefits to patients, whether it is beneficial to patients or the research and development of anti-tumor drugs, rather than experimenting with patients.

Different new drugs have strict restrictions on the patient's disease, condition, and past treatment during clinical trial, and only those who meet the conditions can be used.

However, the patient must have some common basic conditions: (1) have pathological or cytologically confirmed malignant tumors, (2) the patient is in good general condition, can basically take care of himself, and the expected survival time is more than 3 months, (3) has measurable or evaluable tumor lesions, (4) the blood routine and biochemical tests are normal or meet the requirements of a certain standard, (5) there is no serious heart, liver or kidney disease, (6) if other anti-tumor drugs have been used recently, the drug should be discontinued for at least 4 weeks, (7) the patient signs the informed consent form, and (8) the patient has the conditions to come for follow-up or follow-up.