Solid tumors (including lung cancer, liver cancer, esophageal cancer, stomach cancer, nasopharyngeal cancer, urothelial carcinoma, and other MSI-H/dMMR solid tumors)
Conditions
Interventions
Observation group:None
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male/female participants who are at least 18 years of age on the day of signing informed consent; 2.The participant must provide (or legally acceptable representative if applicable) written informed consent for the trial; 3.Histologically confirmed diagnosis of solid tumors, including of lung cancer,HCC,esophageal cancer, gastric cancer,nasopharyngeal cancer, urothelial carcinoma and other MSI-H/dMMR solid tumors,which is all of the following conditions applies:(1) Local treatment methods cannot cure the disease;(2) Patients with recurrence or metastasis after at least one line of systemic treatment (targeted, immunological and/or chemotherapy); (3) More than 6 months have passed since the end of advanced systemic treatment when signing the informed consent form;(4) No primary cancer in other parts; 4.The estimated survival period is more than 6 months; 5.There must be at least one or more measurable lesions that meet the RECIST 1.1 criteria; 6.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; 7.Have adequate organ function as defined in the following table; 8.Have provided archival tumor tissues which can be provided for PD-L1 testing (if previously tested, no additional testing is required) 9.The anticipant can be allowed to have received treatment with an immune checkpoint inhibitor or an ADC drug; 10.A female participant is eligible to participate if she is not pregnant; 11. Women of childbearing age are willing to adopt two contraceptive measures, or undergo surgical sterilization, or refrain from sexual activity from the beginning of the study until 180 days after the last dose of medication is administered. Women of childbearing age are defined as those who have not undergone surgical sterilization or have not experienced menopause for more than one year; 12.A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days; 13. Informed consent, voluntary participation. The process of obtaining informed consent should comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1.The metastatic lesions can be cured through local treatment; 2.Have an Eastern Cooperative Oncology Group (ECOG) performance status is greater than 3; 3.The patient has undergone radiotherapy to the target lesion or other local treatment (such as surgery) within 2 weeks prior to enrollment, ,or has not recovered from adverse events from previous treatments (such as <= grade 1, or returning to baseline). However, the following situations can be excluded: neurotoxicity <= grade 2, alopecia <= grade 2, or laboratory tests as specified in item (7) of the inclusion criteria; 4.Has participated in a clinical trial within the 4 weeks prior to enrollment(excluding those who were in the follow-up period and had not received any treatment); 5.Rapidly progressing tumors (such as tumor bleeding, uncontrollable tumor pain, etc.); 6.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 7.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) or other solid tumor or hematologic malignancy that have undergone potentially curative therapy; 8.Has known active CNS metastases and/or uncontrolled seizure; 9.Has Accepted transplants of foreign genetic tissues or actual organs; 10.Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 11.Has an active infection requiring systemic therapy; 12.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator; 13.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; 14.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment; 15.Has previously received treatment with two or more types of immune checkpoint inhibitors or ADC drugs; 16.Has a known history of Human Immunodeficiency Virus (HIV) testing is not required unless mandated by local health authority; 17.Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA) infection; 18. Has received live vaccines within 30 days prior to the experiment; 19. Patients with active immune diseases requiring systemic treatment (such as the use of remission drugs, glucocorticoids, or immunosuppressants) or at risk of autoimmune diseases (such as antinuclear antibody positive) within 2 years before enrollment. However, replacement therapy such as thyroxine, insulin, and the use of physiological doses of glucocorticoids due to adrenal or pituitary insufficiency are excluded;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month Progression-free survival rate;Overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactYan Jing
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed