New drug combo shows promise for rare kidney cancer

NCT ID NCT05220267

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests a combination of two drugs—anlotinib (a pill that blocks blood vessel growth to tumors) and sintilimab (an IV immunotherapy that helps the immune system attack cancer cells)—as a first treatment for people with advanced non-clear cell renal cell carcinoma, a rare and aggressive kidney cancer. The study includes about 44 adults with various subtypes of this cancer. Researchers are measuring how long the cancer stays under control and how many patients respond to the treatment.

What this could mean

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

Active substance
Anlotinib plus Sintilimab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with a rare and hard-to-treat form of kidney cancer.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 44 participants, so results may not apply broadly. The drug combination can cause side effects like fatigue, high blood pressure, or immune-related reactions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

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

Started

Feb 2022

Expected to finish

Dec 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

18 years and older

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: * Subjects voluntarily joined the study and signed informed consent; * Aged \> 18 years; * ECOG body status score is 0 or 1,Expected survival time is greater than 3 months. * Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. * Patients must have measurable lesions as defined by the RECIST 1.1 standard; * Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment: 1. Absolute neutrophil count (ANC) ≥1.5x 109/L 2. Lymphocyte count ≥ 500/uL. 3. Platelet count ≥ 80x109/L. 4. Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN. 6. Serum bilirubin ≤ 1.5 x ULN. 7. Creatinine clearance ≥ 60 mL/min. 8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab. * Signed informed consent form. * Ability and capacity to comply with study and follow-up procedures. Exclusion Criteria: * Those who are known to be allergic to pharmaceutical ingredients. * Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1; * Previous use of anlotinib or other angiogenesis inhibitors * The patient has any active autoimmune disease or a history of autoimmune disease; * There are uncontrolled heart clinical symptoms or diseases; * Patients with congenital or acquired immune deficiency; * Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment; * A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment; * Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism; * Those with active bleeding or bleeding tendency; * Presence of a drug uncontrolled hypertension; * Urine routine indicates more than urinary protein 2+; * Correct QT interval \> 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study; * Patients suspected of having other primary cancers; * Those who are known to be allergic to pharmaceutical ingredients. * Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen \[anti-HBc\] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1. * Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA. * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060, China