Cancer of Unknown PrimaryPhase 2NCT04848597
PD-1 Inhibitor and Nab-paclitaxel and Bevacizumab in CUP
A Phase 2 study testing Recombinant humanized anti-PD-1 monoclonal antibody injection in people with Cancer of Unknown Primary, run by Fudan University at 1 site in China.
Trial summary
This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Unknown Primary
- What is being tested?
- Recombinant humanized anti-PD-1 monoclonal antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2021to 3 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma;
- Patients whose primary lesions cannot be found after standard evaluation prior to treatment: detailed history, physical examination, blood test, chest and pelvic CT, PET/CT (optional), endoscopy of symptomatic sites, and pathological examination;
- Measurable lesions (RECIST 1.1 criteria);
- Patients who have progressed after receiving first-line treatment for Carcinoma of Unknown Primary. For example, those who have received paclitaxel or docetaxel in the first-line treatment and progressed more than three months after the end of last treatment;
- ECOG of 0-2;
- Life expectancy>3 months;
- Within 7 days (including 7 days) before screening, the laboratory test data requirements: neutrophil count ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90g/L (No blood transfusion in 14 days), serum total bilirubin ≤1.25 times the upper limit of normal (ULN); ALT and AST≤2.5 x ULN (patients with liver metastases ≤5x ULN); serum creatinine ≤1.25 x ULN
Who cannot join
- Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody;
- Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment;
- A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured;
- Symptomatic brain or meningeal metastases (unless the patient receives treatment for> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xichun Hu, 13816110335, xchu2009@hotmail.com
About this study
Official title: Phase 2, Open-label, Single Center, Prospective Study of Recombinant Humanized Anti-PD-1 Monoclonal Antibody Combined With Nab-paclitaxel and Bevacizumab in the Second-line Treatment of Patients With Cancer of Unknown Primary (CUP)
This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors.
Read the detailed description
Recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab treatment, once every 3 weeks, treatment until disease progression, intolerable adverse reactions, patient death or withdrawal informed agree.After treatment, the patients was followed up every 9 weeks for follow-up treatment and survival.
- Conditions
- Cancer of Unknown Primary
- Being tested
- Recombinant humanized anti-PD-1 monoclonal antibody injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant humanized anti-PD-1 monoclonal antibody injectionDrug
Also called Albumin Paclitaxel, bevacizumab
200mg , once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Recombinant humanized anti-PD-1 monoclonal antibody injection:200mg once every 3 weeks Receives: Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards.
ORR is defined as CR+PR
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start13 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion3 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of Unknown PrimaryStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848597
- Sponsor's protocol ID
- CUP-002
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Zhao T, Xu M, Guo Y, Wang Q, Wang Y, Zhou L, Hu S, Xu Q, Hu X, Liu X, Luo Z. Anti-PD-1 plus nab-paclitaxel and bevacizumab for second-line treatment of cancer of unknown primary (Fudan CUP-002): a phase II trial. Nat Commun. 2026 May 9;17(1):6263. doi: 10.1038/s41467-026-72745-6.
PubMed 42103741
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-label, Single Center, Prospective Study of Recombinant Humanized Anti-PD-1 Monoclonal Antibody Combined With Nab-paclitaxel and Bevacizumab in the Second-line Treatment of Patients With Cancer of Unknown Primary (CUP)
- ClinicalTrials.gov ID
- NCT04848597
- Acronym / sponsor ID
- CUP-002
- Conditions
- Cancer of Unknown Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 3 May 2023 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors.
Detailed description
Recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab treatment, once every 3 weeks, treatment until disease progression, intolerable adverse reactions, patient death or withdrawal informed agree.After treatment, the patients was followed up every 9 weeks for follow-up treatment and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Recombinant humanized anti-PD-1 monoclonal antibody injectionRecombinant humanized anti-PD-1 monoclonal antibody injection:200mg once every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma;
- Patients whose primary lesions cannot be found after standard evaluation prior to treatment: detailed history, physical examination, blood test, chest and pelvic CT, PET/CT (optional), endoscopy of symptomatic sites, and pathological examination;
- Measurable lesions (RECIST 1.1 criteria);
- Patients who have progressed after receiving first-line treatment for Carcinoma of Unknown Primary. For example, those who have received paclitaxel or docetaxel in the first-line treatment and progressed more than three months after the end of last treatment;
- ECOG of 0-2;
Key exclusion criteria (5 listed)
- Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody;
- Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment;
- A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured;
- Symptomatic brain or meningeal metastases (unless the patient receives treatment for> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant humanized anti-PD-1 monoclonal antibody injectionAlso: Albumin Paclitaxel, bevacizumab200mg , once every 3 weeks | Drug | Single Arm |
Primary outcome
objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards.
Time frame: Approximately 24 months
ORR is defined as CR+PR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 42103741Zhang X, Zhao T, Xu M, Guo Y, Wang Q, Wang Y, Zhou L, Hu S, Xu Q, Hu X, Liu X, Luo Z. Anti-PD-1 plus nab-paclitaxel and bevacizumab for second-line treatment of cancer of unknown primary (Fudan CUP-002): a phase II trial. Nat Commun. 2026 May 9;17(1):6263. doi: 10.1038/s41467-026-72745-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant humanized anti-PD-1 monoclonal antibody injection in people with Cancer of Unknown Primary, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xichun Hu, MD, PhD (64175590 ext. 85006, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards. (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.