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Experimental combo aims to reboot immune system against Hard-to-Treat cancers

NCT ID NCT02961101

Disease control Sponsor: Han weidong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing an anti-PD-1 antibody (a type of immunotherapy) alone or combined with low-dose decitabine and/or standard chemotherapy in people whose cancers have come back or not responded to treatment. The trial includes patients with several cancer types, such as lymphoma, lung, breast, and liver cancers. The goal is to see if these combinations are safe and effective at shrinking tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-PD-1 antibody (a drug that helps the immune system attack cancer) and low-dose decitabine (a chemotherapy-like drug)
What this could lead to
If successful, this could provide a new treatment option for patients with several types of cancer that have not responded to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply broadly. Side effects from the combination therapy are possible and are being closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Start date

May 2016

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have histological confirmation of relapsed or refractory malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer. 2. 12 to 75 years of age. 3. ECOG performance of less than 2. 4. Life expectancy of at least 3 months. 5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion \>1 cm per RECIST1.1. 6. Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7. Subjects must have adequate bone marrow, live, renal, lung and heart functions. 1. Absolute neutrophil count greater than or equal to 1,000/μL. 2. Platelet count greater than or equal to 70,000/µL. 3. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN). 4. Serum creatinine less than or equal to 1.5 x ULN. 5. Alanine aminotransferase \[ALT or SGPT\] and aspartate aminotransferase \[AST or SGOT\] less than or equal to 2.5 x ULN. Exclusion Criteria: 1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially. 3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4. Prior organ allograft. 5. Women who are pregnant or breastfeeding. 6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

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Conditions

The condition(s) this trial relates to.

bile duct cancer breast cancer cancer childhood kidney cell carcinoma digestive system cancer hepatocellular carcinoma Hodgkins lymphoma lung cancer malignant pancreatic neoplasm neoplasm non-Hodgkin lymphoma ovarian cancer Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignancies multiple

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Biotherapeutic Department of Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.