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

NCT07046650 | Recruiting Phase 2

• 1 other identifier: 2501313
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

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

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Incidence of adverse events (AE)

  through study completion, an average of 2 years

• During of response

  through study completion, an average of 1 year

• Progression Free Survival

  through study completion, an average of 1 year

• Overall Survival

  2 years

Study Arms (4)

Rare Tumor 2

EXPERIMENTAL

Patients with extramammary PAGET's disease, after PD1 failure.

Combination Product: cisplatin-based chemotherapy

Rare Tumor 3

EXPERIMENTAL

Patients with advanced adrenocortical carcinoma, following PD1 failure.

Combination Product: cisplatin-based chemotherapy

Rare Tumor 4

EXPERIMENTAL

Patients with advanced urachal cancer, after PD1 failure.

Combination Product: cisplatin-based chemotherapy

Arm 1

NO INTERVENTION

Patients with advanced urothelial cancer in whom PD-1 and vedicitumumab had failed.

Interventions

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.

Rare Tumor 2; Rare Tumor 3; Rare Tumor 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. Have adequate organ function: 9. Blood routine: Absolute Neutrophil Count (ANC) 1.5×109/L, Platelet (PLT) ≥70×109/L, Hemoglobin (HGB) ≥80g/L; 10. Liver function: serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; Patients who met the above criteria after conventional liver-protective therapy and could be stable for at least 1 week could be enrolled after investigator's evaluation.
• \. Renal function: creatinine clearance ≥60 mL/mi (using the standard Cockcroft-Gault formula) : 12. Coagulation: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as the PT and INR are within the prescribed range of anticoagulant drugs 13. Estimated survival time ≥3 months; 14. Contraception during treatment 15. Ability to adhere to study access schedules and other protocol requirements.

You may not qualify if:

• \. 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.
• \. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness and constipation; 8. Patients with a history of active tuberculosis; 9. Patients who underwent major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the initiation of study treatment; Or have a wound or fracture that has not healed for a long time; 10. Currently participating or having participated in another clinical investigator within 4 weeks before study initiation 11. Patients with a history of severe allergies 12. Is at risk for bleeding, or has coagulopathy, or is receiving thrombolytic therapy 13. People who have a history of psychotropic drug abuse and cannot quit or have mental disorders 14. Subjects who, in the investigator's judgment, had a concomitant medical condition that seriously compromised the safety of the subjects or interfered with the completion of the study, or who were deemed to be ineligible for enrollment for any other reason. "There was a clear previous history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizure prone episodes.
• \. The presence of concomitant diseases (such as severe diabetes mellitus, thyroid disease, and psychosis), or serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that, in the judgment of the investigators, seriously compromise the safety of the subjects or prevent the subjects from completing the study, or the presence of serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that affect the safety of the patients or prevent the patients from providing informed consent, "Or the presence of any psychological, family, sociological, or geographic factors that affect the study protocol and follow-up plan.
• \. The investigator did not consider it appropriate to participate in the trial for any reason

Sponsors & Collaborators

• Sheng Zhang: lead

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Sheng Zhang, PhD

CONTACT

86+18017317442; 568841700@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-01

Locations

CN (1)