Please assess the completion status of the following clinical trial:

Trial Title: Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients with histologically or cytologically confirmed diagnoses of GI malignancies, deemed incurable (inoperable and locally advanced or metastatic), and X-ray computed tomography (CT)-evaluable (measurable or non-measurable) disease, with or without contrast enhancement~   Patients must have one the following carcinomas (including adenocarcinomas, signet ring cell, and mucinous carcinomas) to be eligible to be included in the study:~  1. Esophagus (non-squamous) and GE junction~  2. Stomach~  3. Hepatocellular carcinoma~  4. Pancreas (exocrine) and ampulla~  5. Cholangiocarcinoma (intra-hepatic)~  6. Bile ducts and gall bladder~  7. Small bowel~  8. Large bowel~  9. Rectum~2. Age 18-year or older~3. ECOG Performance Status ≤ 2~4. Estimated life expectancy of at least 3 months~5. Adequate bone marrow function (absolute neutrophil count ≥1500/mm3, hemoglobin ≥9.5 g/dl, and a platelet count ≥100,000/mm3~6. Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase ≤3× upper limit of normal \[ULN\], albumin ≥30 g/L, normal INR of prothrombin time (unless on coumadin treatment)~7. Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥45 ml/min/1.73m2).~8. A ≥21-day treatment-free interval from chemotherapeutic treatment, with the exception of 5-FU, capecitabine and biological therapies, where ≥14-day treatment-free intervals suffice.~9. No other myelosuppressive treatment within 4 weeks of initiation of the study drug.~10. No prior intravenous treatment with mitomycin-C, either alone or in combination~11. No prior oxaliplatin treatment for inoperable locally advanced or metastatic disease~12. A ≥6-month treatment-free interval from oxaliplatin, if given as adjuvant therapy or as neoadjuvant therapy for potentially operable disease~13. No prior extensive radiotherapy (e.g., whole pelvis, total neuroaxis or greater than 50% of neuroaxis, whole abdomen, whole body or half body) or bone marrow transplantation with high-dose chemotherapy and/or total body irradiation.~14. Women of child-bearing potential must be practicing an acceptable method of birth control.~15. Understanding of study procedures and willingness to comply throughout the entire course of the study and to provide written informed consent~Exclusion Criteria:~1. Patients with squamous cell cancer, stromal tumor, sarcoma, neuroendocrine tumor~2. Known hypersensitivity to the study drugs or to any of their components~3. Cirrhosis (Child-Pugh Class C score)~4. Serum albumin level \< 3.0 g/dl~5. Any other severe concurrent disease, which in the judgment of the investigator, would make the subject inappropriate for entry into this study~6. History of human immunodeficiency virus (HIV) infection~7. History of chronic active hepatitis, including subjects who are carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV).~8. Uncontrolled diabetes: HgbA1C≥7.5%,~9. Presence of uncontrolled infection~10. Evidence of active bleeding or bleeding diathesis~11. Untreated (no surgery, no radiation) brain metastases, whether patient is symptomatic or asymptomatic. Patients with brain metastases treated by surgery or radiation who are stable and symptom-free requiring ≤4 mg dexamethasone/day, are eligible.~12. Pregnant or lactating women~13. Treatment with other investigational non-myelosuppressive drugs within 14 days of start of the study drug, and/or with myelosuppressive agents within 28 days of start of the study drug.~14. Uncontrolled ascites (defined as 2 or more palliative taps within 30 days of screening

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Promitil 1.6 mg/kg (Type: EXPERIMENTAL): PROMITIL (1.6 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h
- Promitil 2.0 mg/kg (Type: EXPERIMENTAL): PROMITIL (2.0 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: feasibility