A Phase 2 interventional study of Tislelizumab plus chemotherapy in Cancer of Unknown Primary, Bone Cancer Metastatic and Tislelizumab, sponsored by Wei Xu. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Wei Xu · Phase 2, Interventional, and Treatment
Through scientific and rigorous design, implementation, follow-up and statistics, the sponsor aims to explore the clinical efficacy and safety of Tislelizumab combined with chemotherapy (platinum + paclitaxel) in the treatment of patients with bone metastases cancer with unknown primary, and provide a better treatment plan for these patients.
Unknown primary metastatic carcinoma is a general term for independent metastatic tumors, which are histologically confirmed as metastatic carcinoma but whose primary anatomic site cannot be determined after examination. It accounts for about 3% \~ 5% of all new cancers in humans, and is the 7th \~ 8th most common malignant tumor and the 4th most common fatal cancer in humans.CUP is typically characterized by aggressive and early metastasis and unpredictable metastasis. The disease is not a single disease, but a heterogeneous collection of tumors composed of different primary tumor types that cannot be recognized Bone is the third most common site of CUP, and bone metastases from cancer of unknown primary (BMCUP) is a type of CUP with poor overall prognosis. The primary site of the tumor was determined. BMCUP is a type of heterogeneous tumor with bone metastases confirmed by biopsy but whose primary anatomic site cannot be determined after detailed history, physical examination and relevant experimental examination.BMCUP accounts for about 10% of CUP, which is common in adults with a median onset age of 65-90 years and slightly more in men than women.The spine is the most common site of BMCUP, followed by the pelvis and long bones.Adenocarcinoma was the main pathologic type of BMCUP, with low and medium differentiated adenocarcinoma (64%), undifferentiated carcinoma (20%), neuroendocrine carcinoma (9%) and squamous cell carcinoma (7%).Patients with BMCUP usually have a poor prognosis, with an average survival of 3 to 12 months.
Currently, empire-based chemotherapy, including platinum and taxanes, is still the main treatment for CUP and BMCUP, but the effect is not ideal and the survival rate is very low (median overall survival, about 6-9 months).In recent years, gene expression profiling is a new diagnostic technique, which makes it possible to predict the origin of tumor tissue based on the expression profiling of specific sites. Several of these molecular profiling methods, including reverse transcription polymerase chain reaction (RT-PCR) analysis and DNA microarray analysis, have been developed to trace the primary foci of CUP and BMCUP. In addition, the results of gene expression profiling can indicate the information of tumor genetic abnormalities and thus potential targeted drugs. However, Hayashietal etal., published in JCO in 2019, concluded that "although the prediction of the primary site seems to have prognostic value,However, cuP-site-specific therapy based on microarray mapping did not result in a significant improvement in 1-year survival compared with empirical platinum-paclitaxel therapy ". At present, the systemic treatment of CUP and BMCUP is still not ideal, and finding new effective and safe drug treatment is the key research content of this kind of disease.
In recent years, with the deepening of the research on the regulation mechanism of the immune system and the emergence of immune checkpoint inhibitors, biological therapy with tumor immunotherapy as the core has developed rapidly, and now has become another major cancer treatment mode after chemotherapy and targeted drugs. When the body encounters cancer cells, antigen presenting cells (APC) capture antigen (Ag) and present it to T cells. After activation of T cells, programmed cell death protein 1 (PD-1) receptor can be expressed in T cells and transmit negative regulatory signals to T cells by binding to PD-L1 ligand on tumor cells and APC surface, thus inhibiting the immune response. Immune checkpoint inhibitors block the binding of the PD-1 receptor to the PD-L1 ligand, thereby enhancing the anti-tumor immune response.Pd-1 and PD-L1 inhibitors play a significant antitumor effect in lung cancer, melanoma, kidney cancer and other malignant tumors, but there are no literature reports on the efficacy and safety of immune checkpoint inhibitors in CUP and BMCUP. According to the search results of our treatment group, ClinicaTtrails. Gov has registered clinical trials under research, and the studies related to the application of immune checkpoint inhibitors in CUP include Tom Baker Cancer Center in Canada, a prospective single-arm study of paprizumab monotherapy in CUP patients with poor prognosis, which is still recruiting patients.
Tislelizumab is a humanized IgG4 monoclonal antibody against PD-1, which is an "immune checkpoint" inhibitor. It can bind to the PD-1 receptor on the cell surface and block the binding of PD-L1 and PD-L2. Thus, the escape state of tumor immunity is reversed and the killing activity of T cells is restored. Compared with other PD-1 antibodies, Tislelizumab can reduce the binding of FcγR on macrophages, thereby reducing antibody-dependent phagocytosis and possibly improving the resistance of PD-1 antibodies. It was approved for market in China on December 26, 2019. For the treatment of patients with recurrent or refractory classic Hodgkin's lymphoma, urothelial carcinoma, non-small cell lung cancer, hepatocellular carcinoma. In terms of safety, the most common grade 3 or higher adverse reactions associated with Tislelizumab were elevated glutamyltransferase, anemia, and glutamic-oxalacetic transaminase.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 27 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Wei Xu is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with bone metastases from cancer of unknown primary (BMCUP) diagnosed according to the criteria defined in the 2015 European Society of Medical Oncology (ESMO) clinical Practice Guidelines and with bone metastases confirmed by imaging and histology that cannot be completely resected 1. Cisplatin: 100mg/m2, injected intravenously every 3 weeks, 8 cycles (period 21 days) 2. Paclitaxel (albumin-bound) : paclitaxel, 175mg/m2, given intravenously every 3 weeks for 8 cycles (period 21 days). 3. Tislelizumab: 200mg, given intravenously every 3 weeks until disease progression or unacceptable toxicity or death or subject withdrawal of informed consent.
Drug: Tislelizumab plus chemotherapy
Drug page: Tislelizumab
1. Cisplatin: 100mg/m2, injected intravenously every 3 weeks, 8 cycles (period 21 days) 2. Paclitaxel (albumin-bound) : paclitaxel, 175mg/m2, given intravenously every 3 weeks for 8 cycles (period 21 days). 3. Tislelizumab: 200mg, given intravenously every 3 weeks until disease progression or unacceptable toxicity or death or subject withdrawal of informed consent.
Also known as: Cisplatin, Paclitaxel
Complete Response(CR) and Partial Response(PR) in all participants according to RECIST,v1.1
Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit
Time frame: 3 years
Disease control rate（DCR）according to RECIST,v1.1
Proportion of patients whose tumors shrank or remained stable for a certain amount of time
Time frame: 3 years
Duration of remission (DOR) by Kaplan-Meier
The time between the first tumor evaluation for CR or PR and the first evaluation for PD (Progressive Disease) or death from any cause
Time frame: 3 years
Progression Free Survival (PFS) by Kaplan-Meier
The time span from the start of treatment to the onset of secondary growth
Time frame: 3 years
Overall survival (OS) by Kaplan-Meier
The time between randomization and the death of the patient from any cause
Time frame: 3 years
The median of Progression Free Survival (PFS) by Kaplan-Meier
Fifty percent of patients survival with respect to the The time span from the start of treatment to the onset of secondary growth
Time frame: 3 years
The median of overall survival (OS) by Kaplan-Meier
Fifty percent of patients survival with respect to The time between randomization and the death of the patient from any cause
Time frame: 3 years
Stratified analysis based on clinical features and PD-L1 expression
Stratified analysis
Time frame: 3 years
Adverse effects (AEs) according to NCI-CTCAE, v5.0
The occurrence of adverse events was recorded
Time frame: 3 years
The quality of life according to QoF(sf-36)
Quality of life was recorded
Time frame: 3 years
Plan to share: Yes — After completion
Supporting information: Study protocol
Time frame: After completion
Access criteria: 1111
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Jun 2023, 19 months after the start.
Of 335 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 99. This study's planned 19 months is below that.
Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tislelizumab
Wei Xu