Phase 2 Kidney Cancer Trial, Recruiting NCT05768464 Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05768464
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 18 and 75 years old
  • People who have been diagnosed with a specific type of kidney cancer (non-clear cell renal cell carcinoma), confirmed by a tissue biopsy — specifically certain subtypes such as papillary RCC (at a certain stage and grade), collecting duct carcinoma, renal medullary carcinoma, FH-RCC, TFE3/TFEB translocation-related kidney cancer, or unclassified kidney cancer meeting certain stage or grade requirements (confirm with trial site for exact subtype eligibility)
  • People whose kidney tumour has been fully removed by surgery (partial or full kidney removal), performed no sooner than 3 weeks and no later than 12 weeks before joining the trial
  • People who show no signs of remaining tumour or spread to other parts of the body after surgery — or, if there was a single isolated spread to soft tissue, people whose metastasis was also fully removed with no remaining disease
  • People who have not yet received any systemic (whole-body) treatment for their kidney cancer
  • People who are generally well enough to carry out normal daily activities with little to no limitation (as assessed by a standard medical scale)
  • People whose blood counts, kidney, liver, and heart function all fall within acceptable ranges as measured by blood tests, and whose heart pumping function is at least 50%
  • People who are willing and able to use highly effective contraception during the trial and for 3 months after the last dose
  • People who are able and willing to attend all required study visits and follow-up appointments
  • People who have signed a form confirming they understand and agree to take part in the trial

Who may not be able to join:

  • People whose kidney cancer is of the clear cell, chromophobe, or eosinophilic subtype
  • People who have previously received immunotherapy treatments targeting the immune system (such as anti-PD-1, PD-L1, or CTLA-4 drugs, or certain cytokine therapies)
  • People who have previously received treatments targeting VEGF, VEGFR, or mTOR (specific cancer-targeting drug pathways)
  • People who have taken part in another clinical drug trial within the past 4 weeks, or who have had major surgery within 4 weeks before joining
  • People who have taken certain traditional Chinese medicines, steroid medications (above a low threshold), or immune-suppressing drugs within the 2 weeks before joining — though people on low-dose steroids with no active autoimmune disease may still be considered (confirm with trial site)
  • People who still have unresolved side effects from a previous cancer treatment — though people with permanent but stable side effects not expected to worsen may still be considered (confirm with trial site)
  • People who have had another cancer in the past 5 years that is active or requires treatment — with some exceptions for certain fully treated skin cancers or early-stage cancers in situ (confirm with trial site)
  • People who have a history of cancer spreading to the brain, or whose recent scans (within 30 days) show brain involvement
  • People with high blood pressure that cannot be adequately controlled with medication (remaining at or above 150/100 mmHg)
  • People who have experienced a heart attack, unstable chest pain, heart surgery or stenting, heart bypass surgery, severe heart failure, stroke, or a mini-stroke within the past 6 months
  • People with a significantly prolonged heart electrical interval (QTc of 500 milliseconds or more) on a heart tracing
  • People with a history of serious or active bleeding within the past 30 days, or coughing up blood within the past 6 weeks
  • People who have had a blood clot in a deep vein or in the lungs within the past 6 months
  • People with significant digestive system problems, including conditions affecting how oral medications are absorbed, active stomach ulcers treated within the past 6 months, recent gastrointestinal bleeding without confirmed healing, or conditions that may increase the risk of bowel perforation or inflammation
  • People who have had an organ transplant that requires long-term steroid treatment
  • People who have current or past non-infectious lung inflammation requiring steroid treatment
  • People with an active infection needing treatment, a known HIV diagnosis, or active hepatitis B or C infection
  • People who have received a live vaccine within 30 days before joining
  • People with a known history of serious drug allergies
  • People with a known history of significant psychiatric illness or substance misuse
  • People with wounds that have not yet healed
  • People who have taken, or are expected to take, certain medications that strongly interact with the CYP3A4/5 enzyme pathway within 7 days before joining (confirm specific medications with trial site)
  • People whom the trial doctors consider unsuitable for any medical or safety reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: hongqian guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phone: 15050589789

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Registry
ClinicalTrials.gov
Start date
1 February 2023
Est. completion
30 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

DFS

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov