Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07046650

Multi-cohort, Single-arm, Phase II Study of the Efficacy and Side Effects of Cisplatin Plus Gemcitabine in the Treatment of PD1 Failure or Intensive Treatment of Some Rare Tumors

Led by Sheng Zhang · Updated on 2025-07-01

84

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multi-cohort, single-arm, phase II study of the efficacy and side effects of cisplatin plus gemcitabine in the treatment of PD1 failure or intensive treatment of some rare tumors

CONDITIONS

Official Title

Multi-cohort, Single-arm, Phase II Study of the Efficacy and Side Effects of Cisplatin Plus Gemcitabine in the Treatment of PD1 Failure or Intensive Treatment of Some Rare Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained before enrollment
  • Age 18 to 75 years old
  • Confirmed diagnosis of corresponding cancer by histological or cytological examination
  • Consent to receive treatment
  • ECOG performance status of 0 or 1
  • Prior PD-1 therapy failure
  • At least one measurable lesion (≥10 mm for non-nodal, ≥15 mm for nodal lesions by CT scan)
  • Adequate organ function including blood counts, liver function (specific limits for bilirubin, ALT, AST, albumin, ALP), and kidney function with creatinine clearance ≥60 mL/min
  • Coagulation parameters within specified ranges
  • Estimated survival time of at least 3 months
  • Use of contraception during treatment
  • Ability to comply with study schedules and protocol requirements
Not Eligible

You will not qualify if you...

  • Poor patient compliance
  • Prior exposure to cisplatin and/or gemcitabine with documented disease progression
  • Grade 2 or higher myocardial ischemia, myocardial infarction, arrhythmia (QTc≥470ms), or congestive heart failure (NYHA class ≥2)
  • Severe active or uncontrolled infection requiring systemic treatment, including pulmonary tuberculosis
  • Active hepatitis with elevated viral loads above specified limits
  • History of immunodeficiency including HIV or organ transplantation
  • Severe symptoms like nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, constipation
  • History of active tuberculosis
  • Major surgery, open biopsy, or significant injury within 28 days before starting study treatment; unhealed wounds or fractures
  • Participation in another clinical trial within 4 weeks before study start
  • History of severe allergies
  • Risk of bleeding, coagulopathy, or receiving thrombolytic therapy
  • History of psychotropic drug abuse or untreated mental disorders
  • Neurological or psychiatric disorders such as dementia, epilepsy, or seizure episodes
  • Severe or unstable medical, psychiatric, or other conditions that compromise safety or study completion
  • Any other condition deemed inappropriate for participation by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

S

Sheng Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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