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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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSheng Zhang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Written informed consent was obtained before enrollment. 2. Age ≥18 years old; 3. Patients with corresponding cancer confirmed by histological and/or cytological examination; 4. Consent to treatment; 5. ECOG score: 0-1; 6. Previous PD-1 therapy failure; 7. At least one measurable lesion (≥10 mm on CT scan for non-nodal lesions and ≥15 mm on CT scan for nodal lesions according to RECIST criteria).

Disqualifiers

1. Poor patient compliance; 2. Prior exposure to cisplatin and/or gemcitabine and documented progression 3. With ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 4. Severe active or uncontrolled infection (≥CTCAE grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral therapy, including pulmonary tuberculosis infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • cisplatin-based chemotherapy

    Combination product

    Patients were required to have a creatinine clearance of more than 60 and to receive standard doses of cisplatin and gemcitabine (gemcitabine 1000mg /m2 on day 1.8 and cisplatin 70 mg /m2 on day 1, q3w). A total of 4-6 courses of treatment were performed.

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: Rare Tumor 2Experimental treatment 1 intervention
Group B: Rare Tumor 3Experimental treatment 1 intervention
Group C: Rare Tumor 4Experimental treatment 1 intervention
Group D: Arm 1No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

The sum of the proportion of subjects with Complete response or Partial response

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Incidence of adverse events (AE)

Incidence of adverse events (AE)

Time frame
through study completion, an average of 2 years
2

During of response

The time between the start of the first assessment of the tumor as Complete response or Partial response and the second assessment as PD(Progressive Disease) or death from any cause

Time frame
through study completion, an average of 1 year
3

Progression Free Survival

The time, measured in days, from the date of first treatment to disease progression or death from any cause. Disease progression and death were measured in terms of preoccurrence. Progression included radiographic progression or clinical progression as assessed by the investigator.

Time frame
through study completion, an average of 1 year
4

Overall Survival

The time from the date of first treatment to death from any cause, measured in days

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheng Zhang

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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